Paragraph IV Patent Certifications

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Paragraph IV Patent Certifications
As of August 3, 2007

Below is a list of drug products for which an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification. This list includes the name of the drug product, dosage form, strength (subject of Paragraph IV certification), reference listed drug (RLD), and the date on which the first substantially complete generic drug application was submitted to the Agency (on a prospective basis beginning 3/2/04). The Agency will not disclose the identity of the applicant. This information will be updated twice a month and will be as current as the last update. This information should be used for reference only. The Agency will make every effort to ensure the accuracy of the information disclosed in this list. However, any discrepancies or disparities should be discussed with the Regulatory Support Branch at 301-827-5862, before making any decisions based on this information.

Any additions from the preceding list are marked with the icon.

DRUG NAME	DOSAGE FORM	STRENGTH	RLD	DATE OF SUBMISSION
Acarbose	Tablets	25 mg, 50 mg and 100 mg	Precose	3/22/2005
Acetaminophen	Extended-release Tablets	650 mg	Tylenol
Acetaminophen/ Aspirin/ Caffeine	Tablets	250 mg/250 mg/ 65 mg	Excedrin (migraine)
Acetaminophen and Tramadol Hydrochloride	Tablets	325 mg/ 37.5 mg	Ultracet
Acyclovir Sodium	Injection	50 mg/mL, 10 mL and 20 mL vials	Zovirax
Adenosine	Injection	3 mg/mL, 20 mL and 30 mL vials	Adenoscan	4/18/2005
Albuterol Sulfate	Oral Syrup	2 mg(base)/ 5 mL	Ventolin
Albuterol Sulfate	Extended-release Tablets	4 mg and 8 mg	Volmax
Albuterol Sulfate	Inhalation Solution	0.021% and 0.042%	Accuneb	10/19/2005
Albuterol Sulfate/ Ipratropium Bromide	Inhalation Solution	0.083%/ 0.017%	Duoneb
Alendronate Sodium	Tablets	5 mg, 10 mg, 35 mg, 40 mg and 70 mg	Fosamax
Alprazolam	Orally Disintegrating Tablets	0.25 mg, 0.5 mg, 1 mg and 2 mg	Niravam	12/27/2005
Alprazolam	Tablets	0.25 mg, 0.5 mg, 1 mg and 2 mg	Xanax
Almotriptan Malate	Tablets	6.25 mg and 12.5 mg	Axert	12/8/2005
Amifostine	For Injection	500 mg/vial	Ethyol	4/16/2004
Amlodipine Besylate	Tablets	2.5 mg, 5 mg and 10 mg	Norvasc
Amlodipine Besylate and Atorvastatin Calcium Tablets	Tablets	5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/10 mg, 10 mg/20 mg and 10 mg/80 mg	Caduet	12/29/2006
Amlodipine Besylate and Benazepril Hydrochloride	Capsules	2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg	Lotrel	6/9/2004
Amlodipine Besylate and Benazepril Hydrochloride	Capsules	5 mg/40 mg and 10 mg/40 mg	Lotrel	11/17/2006
Aripiprazole	Tablets	2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg	Abilify	11/15/2006
Aripiprazole	Orally Disintegrating Tablets	10 mg, 15 mg, 20 mg and 30 mg	Abilify	11/15/2006
Aspirin and Dipyridamole	Extended-release Capsules	25 mg and 200 mg	Aggrenox	2/1/2007
Atenolol	Tablets	25 mg, 50 mg and 100 mg	Tenormin
Atenolol/ Chlorthalidone	Tablets	50 mg/25 mg and 100 mg/25 mg	Tenoretic
Atomoxetine Hydrochloride	Capsules	10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg	Strattera	5/29/2007
Atorvastatin Calcium	Tablets	10 mg, 20 mg, 40 mg and 80 mg	Lipitor
Azelastine Hydrochloride	Nasal Spray	0.125 mg base/spray	Astelin	11/14/2005
Azelastine Hydrochloride	Ophthalmic Solution	0.05%	Optivar	12/13/2006
Betaxolol	Ophthalmic Solution	0.5%(base)	Betoptic
Brimonidine Tartrate	Ophthalmic Solution	0.1%	Alphagan P	12/20/2006
Brimonidine Tartrate	Ophthalmic Solution	0.15%	Alphagan P	11/03/2006
Brimonidine Tartrate	Ophthalmic Solution	0.2%	Alphagan
Budesonide	Inhalation Suspension	0.25 mg/2 mL and 0.5 mg/2 mL	Pulmicort Respules	9/15/2005
Bupropion Hydrochloride	Extended-release Tablets	100 mg, 150 mg and 200 mg	Wellbutrin SR
Bupropion Hydrochloride	Extended-release Tablets	150 mg	Zyban
Bupropion Hydrochloride	Extended-release Tablets	150 mg and 300 mg	Wellbutrin XL	9/21/2004
Bupropion Hydrochloride	Tablets	75 mg and 100 mg	Wellbutrin
Buspirone Hydrochloride	Tablets	5 mg, 7.5 mg, 10 mg, 15 mg and 30 mg	Buspar
Butorphanol Tartrate	Nasal Spray	10 mg/mL	Stadol NS
Calcipotriene	Topical Solution	0.005%	Dovonex	5/19/2006
Calcitonin-Salmon	Nasal Spray	200 IU/spray	Miacalcin
Calcitonin-Salmon (Recombinant)	Nasal Spray	200 IU/spray	Fortical	3/29/2006
Calcitriol	Injection	1 mcg/mL and 2 mcg/mL, 1 mL vials	Calcijex
Calcium Acetate	Capsules	EQ 169 mg calcium	PhosLo	5/31/2005
Calcium Carbonate/ Famotadine/ Magnesium Hydroxide	Chewable Tablets	800 mg/ 10 mg/ 165 mg (OTC)	Pepcid Complete	11/1/2004
Candesartan Cilexetil	Tablets	4 mg, 8 mg, 16 mg and 32 mg	Atacand	12/22/2006
Captopril	Tablets	12.5 mg, 25 mg, 50 mg, and 100 mg	Capoten
Carbamazepine	Extended-release Capsules	100 mg and 200 mg	Carbatrol	2/2/2006
Carbamazepine	Extended-release Capsules	300 mg	Carbatrol
Carbamazepine	Extended-release Tablets	100 mg	Tegretol-XR	12/30/2005
Carbamazepine	Extended-release Tablets	200 mg and 400 mg	Tegretol-XR
Carbidopa/ Levodopa	Extended-release Tablets	25 mg/100 mg and 50 mg/200 mg	Sinemet CR
Carboplatin	For Injection	50 mg/vial, 150 mg/vial and 450 mg/vial	Paraplatin
Carboplatin	Injection	50 mg/vial, 150 mg/vial and 450 mg/vial	Paraplatin
Carisoprodol/ Aspirin	Tablets	200 mg/ 325 mg	Soma Compound
Carisoprodol/ Aspirin/ Codeine	Tablets	200 mg/ 325 mg/ 16 mg	Soma Compound with Codeine
Carvedilol	Tablets	3.125 mg, 6.25 mg, 12.5 mg and 25 mg	Coreg
Celecoxib	Capsules	100 mg, 200 mg and 400 mg	Celebrex
Cetirizine HCL	Syrup	5 mg/5 mL	zyrtec	3/19/2007
Cetirizine Hydrochloride and Pseudoephedrine	Extended-release Tablets	5 mg/120 mg	Zyrtec-D	6/2/2004
Cetirizine Hydrochloride	Chewable Tablets	5 mg and 10 mg	Zyrtec	3/25/2005
Chlorhexidine Gluconate	Scrub brush/sponge	4%	Hibiclens
Chlorpheniramine Polistirex and Hydrocodone Polistirex	Extended-release Capsules	8 mg/10 mg and 4 mg/5 mg	Tussionex	9/10/2004
Ciclopirox	Gel	0.77%	Loprox	5/10/2006
Ciprofloxacin Hydrochloride	Tablets	100 mg, 250 mg, 500 mg and 750 mg	Cipro
Cisplatin	Injection	1 mg/mL, 10 mL, 50 mL, 100 mL and 200 mL vials	Platinol-AQ
Cisplatin	For Injection	10 mg/vial and 50 mg/vial	Platinol
Clobetasol Propionate	Topical Foam	0.05%	Olux	6/27/2005
Clobetasol Propionate	Lotion	0.05%	Clobex	3/27/2006
Clonidine Hydrochloride	Transdermal System	0.1 mg/day, 0.2 mg/day, and 0.3 mg/day	Catapres-TTS
Clopidogrel Bisulfate	Tablets	75 mg	Plavix
Colestipol Hydrochloride	Tablets	1 g	Colestid	8/23/2005
Conjugated Estrogens	Tablets	0.3 mg and 0.625 mg	Premarin
Cyclobenzaprine Hydrochloride	Tablets	10 mg	Flexeril
Cyclophosphamide	For Injection	100 mg/vial, 200 mg/vial, 500 mg/vial, 1 g/vial and 2 g/vial	Cytoxan
Desloratadine	Tablets	5 mg	Clarinex	6/21/2006
Desloratadine	Orally Disintegrating Tablets	2.5 mg and 5 mg	Clarinex	6/21/2006
Desloratadine and Pseudoephedrine Sulfate	Extended-release Tablets	5 mg/240 mg	Clarinex-D 24 Hour	6/21/2006
Desmopressin Acetate	Injection	4 mcg/mL, 1 mL and 10 mL vials	DDAVP
Desmopressin Acetate	Nasal Spray	0.01%	DDAVP
Desmopressin Acetate	Tablets	0.1 mg and 0.2 mg	DDAVP
Desogestrel; Ethinyl Estradiol Tablets	Tablets	0.15mg/ 0.02 mg and 0.01 mg	Mircette
Dexmethylphenidate Hydrochloride	Tablets	2.5 mg	Focalin	7/27/2004
Dexmethylphenidate Hydrochloride	Tablets	5 mg and 10 mg	Focalin	5/27/2004
Dexmethylphenidate Hydrochloride	Extended-release Capsules	5 mg, 10 mg and 20 mg	Focalin XR	3/30/2007
Dexrazoxane	For Injection	250 mg/vial	Zinecard
Dextroamphetamine saccharate; Amphetamine aspartate; Dextroamphetamine Sulfate; Amphetamine Sulfate	Extended-release Capsules	5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg	Adderall XR
Dextroamphetamine saccharate; Amphetamine aspartate; Dextroamphetamine Sulfate; Amphetamine Sulfate	Tablets	7.5 mg, 12.5 mg and 15 mg	Adderall
Diazepam	Tablets	2 mg, 5 mg and 10 mg	Valium
Diazepam	Rectal Gel	2.5 mg/0.5 mL, 5 mg/mL, 10 mg/2 mL, 15 mg/3 mL and 20 mg/4 mL	Diastat	3/23/2004
Didanosine	Delayed-release Capsules	200 mg, 250 mg and 400 mg	Videx EC	6/1/2004
Diltiazem Hydrochloride	Extended-release Capsules	60 mg, 90 mg and 120 mg	Cardizem SR
Diltiazem Hydrochloride	Extended-release Capsules	120 mg, 180 mg and 240 mg	Dilacor XR
Diltiazem Hydrochloride	Extended-release Capsules	120 mg, 180 mg, 240 mg and 300 mg	Cardizem CD
Diltiazem Hydrochloride	Extended-release Capsules	120 mg, 180 mg, 240 mg, 300 mg, 360 mg and 420 mg	Tiazac
Diltiazem Hydrochloride	Extended-release Tablets	120 mg, 180 mg, 240 mg, 300 mg and 360 mg	Cardizem LA	8/30/2005
Diltiazem Hydrochloride	Extended-release Tablets	420 mg	Cardizem LA	4/25/2005
Divalproex Sodium	Delayed-release Tablets	125 mg, 250 mg and 500 mg	Depakote
Divalproex Sodium	Extended-release Tablets	250 mg	Depakote ER	5/3/2004
Divalproex Sodium	Extended-release Tablets	500 mg	Depakote ER	2/8/2005
Donepezil Hydrochloride	Tablets	5 mg and 10 mg	Aricept
Dorzolamide Hydrochloride	Ophthalmic Solution	2%	Trusopt	10/7/2005
Dorzolamide Hydrochloride and Timolol Maleate	Ophthalmic Solution	2%/0.5%	Cosopt	10/7/2005
Doxazosin Mesylate	Tablets	1 mg, 2 mg, 4 mg and 8 mg	Cardura
Drospirenone and Ethinyl Estradiol	Tablets	3 mg/0.02 mg	Yaz	9/29/2006
Drospirenone and Ethinyl Estradiol	Tablets	3 mg/0.03 mg	Yasmin	1/7/2005
Enalapril Maleate	Tablets	2.5 mg, 5 mg, 10 mg and 20 mg	Vasotec
Enoxaparin Sodium	Injection	100 mg/mL, 0.3 mL, 0.4 mL, 0.6 mL, 0.8 mL and 1 mL prefilled syringes	Lovenox
Enoxaparin Sodium	Injection	150 mg/mL, 0.6 mL, 0.8 mL and 1 mL prefilled syringes	Lovenox
Enoxaparin Sodium	Injection	100 mg/mL, 3 mL vials	Lovenox	12/7/2006
Entacapone	Tablets	200 mg	Comtan	4/11/2007
Eplerenone	Tablets	25 mg and 50 mg	Inspra	9/27/2006
Escitalopram Oxalate	Capsules	5 mg	Lexapro	8/17/2005
Escitalopram Oxalate	Capsules	10 mg and 20 mg	Lexapro	3/30/2005
Escitalopram Oxalate	Tablets	5 mg, 10 mg and 20 mg	Lexapro
Esmolol Hydrochloride	Injection	10 mg/mL, 10 mL vial	Brevibloc
Esomeprazole Magnesium	Delayed-release Capsules	20 mg and 40 mg	Nexium	8/5/2005
Estradiol	Transdermal System	0.0375 mg/day and 0.06 mg/day	Climara
Estradiol	Transdermal System	0.05 mg/day and 0.1 mg/day	Climara	9/12/2005
Estradiol; Estradiol and Norgestimate	Tablets	1 mg; 1 mg and 0.09 mg	Prefest
Etodolac	Extended-release Tablets	400 mg, 500 mg and 600 mg	Lodine XL
Ezetimibe	Tablets	10 mg	Zetia	10/25/2006
Famciclovir	Tablets	125 mg, 250 mg and 500 mg	Famvir	12/28/2004
Famotidine	Injection	10 mg/mL, 2 mL vials; unpreserved	Pepcid
Famotidine	Injection	10 mg/mL, 4 mL and 20 mL vials; preserved	Pepcid
Famotidine	Injection	10 mg/mL, 50 mL vial, pharmacy bulk package; unpreserved	Pepcid
Famotidine	Tablets	10 mg (OTC)	Pepcid AC
Famotidine	Tablets	20 mg and 40 mg	Pepcid
Famotidine	Tablets (Chewable)	10 mg (OTC)	Pepcid AC (chewable)
Felodipine	Extended-release Tablets	2.5 mg, 5 mg and 10 mg	Plendil ER
Fenofibrate	Capsules	67 mg, 134 mg and 200 mg	Tricor
Fenofibrate	Tablets	54 mg, 107 mg and 160 mg	Tricor
Fentanyl	Transdermal Extended-release Film	0.6 mg/24 hr, 1.2 mg/ 24 hr, 1.8 mg/ 24 hr and 2.4 mg/ 24 hr	Duragesic
Fentanyl Citrate	Lozenges	0.2 mg	Actiq	10/29/2004
Fentanyl Citrate	Lozenges	0.4 mg	Actiq	10/6/2004
Fentanyl Citrate	Lozenges	0.6 mg	Actiq	12/20/2004
Fentanyl Citrate	Lozenges	0.8 mg, 1.2 mg and 1.6 mg	Actiq	11/22/2004
Fexofenadine Hydrochloride	Capsules	60 mg	Allegra
Fexofenadine Hydrochloride	Tablets	30 mg, 60 mg and 180 mg	Allegra
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	Extended-release Tablets	60 mg/120 mg	Allegra-D
Finasteride	Tablets	1 mg	Propecia
Finasteride	Tablets	5 mg	Proscar
Flecainide Acetate	Tablets	50 mg, 100 mg and 150 mg	Tambocor
Fluconazole	For Oral Suspension	50 mg/5 mL and 200 mg/5 mL	Diflucan for Oral Suspension
Fluconazole	Tablets	50 mg, 100 mg, 150 mg and 200 mg	Diflucan
Flunisolide	Nasal Solution	0.025%	Nasalide
Fluocinonide	Ointment	0.05%	Lidex
Fluoxetine Hydrochloride	Tablets	10 mg and 20 mg	Prozac
Fluoxetine Hydrochloride	Capsules	10 mg, 20 mg and 40 mg	Prozac
Fluoxetine Hydrochloride	Delayed-release Capsules	90 mg	Prozac Weekly
Fluoxetine Hydrochloride	Oral Solution	20 mg (base)/5 mL	Prozac
Fluoxetine Hydrochloride	Capsules	10 mg and 20 mg	Sarafem
Flutamide	Capsules	125 mg	Eulexin
Fluvastatin Sodium	Extended-release Tablets	80 mg	Lescol XL	3/15/2007
Fosinopril Sodium	Tablets	10 mg, 20 mg and 40 mg	Monopril
Fosinopril Sodium and Hydrochlorothiazide	Tablets	10 mg/12.5 mg and 20 mg/12.5 mg	Monopril HCT
Gabapentin	Capsules	100 mg, 300 mg and 400 mg	Neurontin
Gabapentin	Oral Solution	250 mg/5 mL	Neurontin
Gabapentin	Tablets	100 mg, 300 mg and 400 mg	Neurontin
Gabapentin	Tablets	600 mg and 800 mg	Neurontin
Galantamine Hydrobromide	Extended-release Capsules	8 mg	Razadyne ER	3/2/2006
Galantamine Hydrobromide	Extended-release Capsules	16 mg and 24 mg	Razadyne ER	3/11/2006
Galantamine Hydrobromide	Tablets	4 mg, 8 mg and 12 mg	Razadyne	2/28/2005
Ganciclovir Sodium	Capsules	250 mg and 500 mg	Cytovene
Gatifloxacin	Injection	10 mg/mL, 20 mL and 40 mL vials	Tequin	11/24/2004
Gatifloxacin	Tablets	200 mg and 400 mg	Tequin
Gatifloxacin in Dextrose 5% in Plastic Container	Injection	2 mg/mL, 100 mL and 200 mL containers (plastic)	Tequin	12/13/2004
Gemcitabine	For Injection	200 mg/vial	Gemzar	11/1/2005
Gemcitabine	For Injection	1g/vial	Gemzar	11/14/2005
Glimepiride and Rosiglitazone Maleate	Tablets	1 mg/4 mg, 2 mg/4 mg and 4 mg/4 mg	Avandaryl	12/22/2006
Glipizide	Extended-release Tablets	2.5 mg, 5 mg and 10 mg	Glucotrol XL
Glyburide	Tablets	1.5 mg, 3 mg, 4.5 mg and 6 mg	Glynase
Glyburide/ Metformin Hydrochloride	Tablets	1.25mg/250 mg, 2.5 mg/500 mg and 5 mg/500 mg	Glucovance
Granisetron Hydrochloride	Injection	0.1 mg/mL, 1 mL single dose vial	Kytril	3/8/2007
Granisetron Hydrochloride	Injection	1 mg/mL, 1 mL vials	Kytril	6/1/2004
Granisetron Hydrochloride	Injection	1 mg/mL, 4 mL multi-dose vials	Kytril	7/19/2004
Guaifenesin*	Extended-release Tablets	600 mg and 1.2 gm	Mucinex	6/9/2006
Hydrocodone Bitartrate and Ibuprofen	Tablets	2.5 mg/200 mg	Vicoprofen	2/24/2006
Hydrocodone Bitartrate and Ibuprofen	Tablets	5 mg/200 mg	Vicoprofen	5/27/2005
Hydrocodone Bitartrate and Ibuprofen	Tablets	7.5 mg/200 mg	Vicoprofen
Hydrocodone Bitartrate and Ibuprofen	Tablets	10 mg/200 mg	Vicoprofen
Ibandronate Sodium	Tablets	2.5 mg and 150 mg	Boniva	5/16/2007
Ibuprofen	Oral Drops	40 mg/mL	Children's Motrin Drops
Ibuprofen	Oral Suspension	100 mg/5 mL (Rx)	Motrin
Ibuprofen	Oral Suspension	100 mg/5 mL (OTC)	Children's Motrin
Ibuprofen	Chewable Tablets	50 mg and 100 mg	Children's Motrin, Junior Strength Motrin
Ibuprofen Potassium and Pseudoephedrine Hydrochloride	Capsules	200 mg/30 mg	Advil Cold and Sinus	12/27/2004
Ibuprofen and Pseudoephedrine Hydrochloride	Oral Suspension	100 mg/ 15 mg per 5 mL	Children's Motrin Cold
Ibuprofen and Pseudoephedrine Hydrochloride	Tablets	200 mg/30 mg	Advil Cold and Sinus
Ifosfamide	For Injection	1 g/vial and 3 g/vial	Ifex
Ifosfamide	Injection	50 mg/mL, 20 mL vials and 60 mL vials	Ifex
Ifosfamide/ Mesna	For Injection/ Injection Kit	1 g/vial; 100 mg/mL, 10 mL vials and 3 g/vial; 100 mg/mL, 10 mL vials	Ifex/ Mesnex Kit
Ifosfamide/ Mesna	Injection/ Injection Kit	50 mg/mL, 20 mL and 60 mL vials; 100 mg/mL, 10 mL vial	Ifex/ Mesnex Kit
Imiquimod	Cream	5%	Aldara	10/17/2006
Indomethacin	Extended-release Capsules	75 mg	Indocin SR
Irbesartan	Tablets	75 mg, 150 mg and 300 mg	Avapro	5/25/2004
Irbesartan and Hydrochlorothiazide	Tablets	150 mg/12.5 mg and 300 mg/12.5 mg	Avalide	11/10/2004
Irbesartan and Hydrochlorothiazide	Tablets	300 mg/25 mg	Avalide	6/6/2006
Irinotecan Hydrochloride	Injection	20 mg/mL, 2 mL and 5 mL vials	Camptosar	7/26/2004
Itraconazole	Capsules	100 mg	Sporanox
Ketoprofen	Capsules	25 mg, 50 mg and 75 mg	Orudis
Ketorolac Tromethamine	Injection	15 mg/mL and 30 mg/mL	Toradol
Ketorolac Tromethamine	Ophthalmic Solution	0.5%	Acular
Ketorolac Tromethamine	Ophthalmic Solution	0.4%	Acular LS	1/28/2005
Ketorolac Tromethamine	Tablets	10 mg	Toradol
Ketotifen Fumarate	Ophthalmic Solution	0.025%	Zaditor	12/23/2004
Lactulose	Oral Syrup	10 g/15 mL	Cephulac
Lactulose	Oral Syrup	10 g/15 mL	Chronulac
Lamotrigine	Tablets	25 mg, 100 mg, 150 mg and 200 mg	Lamictal
Lamotrigine	Chewable Tablets	2 mg, 5 mg and 25 mg	Lamictal CD
Latanoprost	Ophthalmic Solution	0.005%	Xalatan
Lansoprazole	Delayed-release Pellets/Capsules	15 mg and 30 mg	Prevacid	12/05/2005
Lansoprazole	Delayed-release Orally Disintegrating Tablets	15 mg and 30 mg	Prevacid	12/27/2006
Letrozole	Tablets	2.5 mg	Femara	3/2/2006
Leuprolide Acetate	Injection (depot)	7.5 mg/vial	Lupron Depot
Levalbuterol Hydrochloride	Inhalation Solution	0.0103%, 0.021% and 0.042%	Xopenex	6/20/2005
Levalbuterol Hydrochloride	Inhalation Solution	0.25%	Xopenex	5/23/2006
Levetiracetam	Tablets	250 mg, 500 mg and 750 mg	Keppra
Levetiracetam	Tablets	1000 mg	Keppra	1/24/2007
Levofloxacin	Injection	5 mg/mL; 50 mL, 100 mL and 150 mL vials	Levaquin in Dextrose 5% in Plastic Container
Levofloxacin	Injection	25 mg/mL	Levaquin
Levofloxacin	Ophthalmic Solution	0.5%	Quixin
Levofloxacin	Tablets	250 mg, 500 mg and 750 mg	Levaquin
Levonorgestrel and Ethinyl Estradiol	Tablets	0.15 mg/0.03 mg	Seasonale	3/29/2004
Levothyroxine Sodium	Tablets	0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.1 mg, 0.112 mg, 0.125 mg, 0.150 mg, 0.175 mg, 0.2 mg and 0.3 mg	Levoxyl
Linezolid	Tablets	600 mg	Zyvox	12/21/2005
Loperamide Hydrochloride and Simethicone	Chewable Tablets	2 mg/125 mg	Imodium Advanced
Loperamide Hydrochloride and Simethicone	Tablets	2 mg/125 mg	Imodium Advanced	12/29/2004
Loratadine	Syrup	1 mg/mL	Claritin
Loratadine	Tablets	10 mg	Claritin
Loratadine	Orally Disintegrating Tablets	10 mg	Claritin RediTabs
Loratadine/ Pseudoephedrine	Extended-release Tablets	5 mg/120 mg	Claritin D-12 hour
Loratadine/ Pseudoephedrine	Extended-release Tablets	10 mg/240 mg	Claritin D-24 hour
Losartan Potassium	Tablets	25 mg, 50 mg, and 100 mg	Cozaar
Losartan Potassium and Hydrochlorothiazide	Tablets	50 mg/12.5 mg and 100 mg/25 mg	Hyzaar	5/24/2004
Losartan Potassium and Hydrochlorothiazide	Tablets	100 mg/12.5 mg	Hyzaar	4/4/2006
Mefloquine Hydrochloride	Tablets	250 mg	Lariam
Megestrol Acetate	Oral Suspension	40 mg/mL	Megace
Metaxalone	Tablets	400 mg	Skelaxin
Metaxalone	Tablets	800 mg	Skelaxin	11/4/2004
Metformin Hydrochloride	Extended-release Tablets	500 mg	Glucophage XR
Metformin Hydrochloride	Extended-release Tablets	750 mg	Glucophage XR
Methylphenidate Hydrochloride	Extended-release Capsules	10 mg, 20 mg and 30 mg	Metadate CD	5/13/2005
Methylphenidate Hydrochloride	Extended-release Capsules	20 mg, 30 mg and 40 mg	Ritalin LA	8/21/06
Methylphenidate Hydrochloride	Extended-release Capsules	40 mg	METADATE CD	3/15/2007
Methylphenidate Hydrochloride	Extended-release Tablets	18 mg, 27 mg, 36 mg and 54 mg	Concerta	7/19/2005
Metoclopramide Hydrochloride	Injection	5 mg/mL, 2 mL, 10 mL, 20 mL and 30 mL vials	Reglan
Metoprolol Succinate	Extended-release Tablets	25 mg, 50 mg, 100 mg and 200 mg	Toprol XL
Metronidazole	Vaginal Gel	0.75%	MetroGel-Vaginal	9/2/2004
Mirtazapine	Tablets	7.5 mg, 15 mg, 30 mg, and 45 mg	Remeron
Mirtazapine	Orally Disintegrating Tablets	15 mg, 30 mg and 45 mg	Remeron SolTab
Modafinil	Tablets	100 mg and 200 mg	Provigil
Moexipril Hydrochloride	Tablets	7.5 mg and 15 mg	Univasc
Moexipril Hydrochloride and Hydrochlorothiazide	Tablets	7.5mg/12.5mg 15 mg/25 mg and 15 mg/12.5 mg	Uniretic	1/15/2004
Mometasone Furoate	Topical Solution (Cream)	0.1%	Elocon
Mometasone Furoate	Topical Solution (Lotion)	0.1%	Elocon	6/10/2004
Montelukast Sodium	Chewable Tablets	4 mg and 5 mg	Singulair	12/26/2006
Montelukast	Tablets	10 mg	Singulair	2/20/2007
Moxifloxacin Hydrochloride	Ophthalmic Solution/Drops	0.5%	Vigamox	12/22/2005
Moxifloxacin Hydrochloride	Tablets	400 mg	Avelox
Nabumetone	Tablets	500 mg and 750 mg	Relafen
Naproxen Sodium	Extended-release Tablets	375 mg (base) and 500 mg (base)	Naprelan
Nateglinide	Tablets	60 mg and 120 mg	Starlix	12/22/2004
Nefazodone Hydrochloride	Tablets	50 mg, 100 mg, 150 mg 200 mg and 250 mg	Serzone
Niacin	Extended-release Tablets	500 mg, 750 mg and 1000 mg	Niaspan
Nicardipine Hydrochloride	Injection	2.5 mg/mL, 10 mL Ampoules	Cardene	12/27/2006
Nicotine	Transdermal System	7 mg/day, 14 mg/day and 21 mg/day	Habitrol
Nicotine Polacrilex	Troche/Lozenge	2 mg and 4 mg	Commit
Nifedipine	Capsules	10 mg and 20 mg	Procardia
Nifedipine	Extended-release Tablets	30 mg, 60 mg and 90 mg	Adalat CC
Nifedipine	Extended-release Tablets	30 mg, 60 mg and 90 mg	Procardia XL
Nitrofurantoin Monohydrate/ Macrocrystals	Capsules	75 mg/25 mg	Macrobid
Nitroglycerin	Sublingual Tablets	0.3 mg, 0.4 mg and 0.6 mg	Nitrostat	10/19/2005
Nitroglycerin	Transdermal System	0.1 mg/hr	Transderm-Nitro
Nitroglycerin	Transdermal System	0.1 mg/hr, 0.2 mg/hr, 0.3 mg/hr, 0.4 mg/hr, 0.6 mg/hr and 0.8 mg/hr	Nitro-dur
Nizatidine	Capsules	150 mg and 300 mg	Axid
Norelgestromin and Ethinyl Estradiol	Transdermal System	0.15 mg/0.02 mg per 24 hours	Ortho Evra	3/22/2007
Norethindrone/ Ethinyl Estradiol	Tablets	0.5 mg/ 0.035 mg, 0.75 mg/ 0.035 mg and 1 mg /0.035 mg	Ortho-Novum 7/7/7, 21 and 28 day
Norethindrone Acetate/ Ethinyl Estradiol	Tablets	1 mg/0.005 mg	Femhrt
Norethindrone Acetate/ Ethinyl Estradiol	Tablets	1 mg/ 0.02 mg, 1 mg/0.03 mg and 1 mg /0.035 mg	Estrostep Fe
Norethindrone Acetate/ Ethinyl Estradiol	Tablets	1 mg/0.02 mg, 1 mg/ 0.03 mg and 1 mg /0.035 mg	Estrostep 21
Norethindrone Acetate/ Ethinyl Estradiol and Ferrous Fumarate	Tablets	1 mg/0.02 mg and 75 mg	Loestrin 24 Fe	4/17/2006
Norethindrone and Ethinyl Estradiol and Ferrous Fumarate	Chewable Tablets	0.4 mg/0.035 mg	Ovcon-35 Fe	4/27/2007
Norgestimate/ Ethinyl Estradiol	Tablets	0.18 mg /0.025 mg, 0.215 mg /0.025 mg and 0.25 mg /0.025 mg	Ortho Tri-Cyclen Lo, 28 day
Norgestimate/ Ethinyl Estradiol	Tablets	0.18 mg /0.035 mg, 0.215 mg /0.035 mg and 0.25 mg /0.035 mg	Ortho Tri-Cyclen, 21 and 28 day
Nortriptyline Hydrochloride	Capsules	10 mg, 25 mg, 50 mg and 75 mg	Pamelor
Octreotide Acetate	Injection	0.05 mg /mL, 0.1 mg /mL and 0.5 mg/mL, 1 mL vials	Sandostatin (Preservative-free)
Octreotide Acetate	Injection	0.2 mg/mL and 1 mg /mL, 5 mL vials	Sandostatin
Ofloxacin	Otic Solution	0.3%	Floxin
Olanzapine	Tablets	2.5 mg, 5 mg, 7.5 mg, 10 mg and 15 mg	Zyprexa
Olanzapine	Tablets	20 mg	Zyprexa
Olanzapine	Orally Disintegrating Tablets	5 mg, 10 mg, 15 mg and 20 mg	Zyprexa Zydis
Olanzapine and Fluoxetine Hydrochloride	Capsules	6 mg/25 mg, 12 mg/25 mg, 6 mg/50 mg and 12 mg/50 mg	Symbyax	1/10/2005
Omeprazole Magnesium	Delayed-release Capsules	20 mg	Prilosec OTC	3/19/2007
Olmesartan Medoxomil	Tablets	5 mg, 20 mg and 40 mg	Benicar	4/25/2006
Olmesartan Medoxomil and Hydrochlorothiazide	Tablets	40 mg/12.5 mg and 40 mg/25 mg	Benicar HCT	2/15/2007
Olopatadine Hydrochloride	Ophthalmic Solution	0.1%	Patanol	7/17/2006
Omeprazole	Delayed-release Capsules	10 mg, 20 mg and 40 mg	Prilosec
Omeprazole and Sodium Bicarbonate	Capsules	20 mg/1100 mg and 40 mg/1100 mg	Zegerid	4/30/2007
Ondansetron Hydrochloride	Injection	2 mg/mL, 2 mL vials (Preservative-free)	Zofran
Ondansetron Hydrochloride	Injection	2 mg/mL, 20 mL vials	Zofran
Ondansetron Hydrochloride	Injection	0.64 mg/mL, 50 mL container (plastic)	Zofran in Plastic Container
Ondansetron Hydrochloride	Oral Solution	4 mg/5 mL	Zofran	12/20/2004
Ondansetron Hydrochloride	Orally Disintegrating Tablets	4 mg and 8 mg	Zofran ODT
Ondansetron Hydrochloride	Tablets	4 mg, 8 mg, 16 mg and 24 mg	Zofran
Oxaliplatin	For Injection	50 mg/vial and 100 mg/vial	Eloxatin	2/9/2007
Oxaliplatin	Injection	5 mg/mL, 10 mL and 20 mL vials	Eloxatin	2/9/2007
Oxandrolone	Tablets	2.5 mg and 10 mg	Oxandrin	6/19/2006
Oxazepam	Capsules	10 mg, 15 mg and 30 mg	Serax
Oxcarbazepine ¹	Tablets	150 mg, 300 mg and 600 mg	Trileptal	5/5/2006
Oxcarbazepine	Oral Suspension	300 mg/5 mL	Trileptal	12/26/2006
Oxybutynin Chloride	Extended-release Tablets	5 mg, 10 mg and 15 mg	Ditropan XL
Oxycodone	Extended-release Tablets	10 mg, 20 mg, 40 mg, 80 mg and 160 mg	Oxycontin
Oxycodone Hydrochloride	Extended-release Tablets	15 mg	Oxycontin	2/15/2007
Oxycodone Hydrochloride	Extended-release Tablets	30 mg and 60 mg	Oxycontin	1/3/2007
Paclitaxel	Injection	6 mg/mL, 5 mL, 16.7 mL, 25 mL, 33.3 mL and 50 mL vials	Taxol
Pamidronate Disodium	For Injection	30 mg/vial, 60 mg/vial and 90 mg/vial	Aredia
Pamidronate Disodium	Injection	30 mg/vial, 60 mg/vial and 90 mg/vial	Aredia
Pantoprazole Sodium	For Injection	40 mg/vial	Prontonix IV	4/7/2005
Pantoprazole Sodium	Delayed-release Tablets	20 mg and 40 mg	Protonix	2/2/2004
Paroxetine Hydrochloride	Capsules	10 mg and 20 mg	Paxil
Paroxetine Hydrochloride	Oral Suspension	10 mg/5 mL	Paxil	2/10/2005
Paroxetine Hydrochloride	Tablets	10 mg, 20 mg, 30 mg and 40 mg	Paxil
Paroxetine Hydrochloride	Extended-release Tablets	25 mg	Paxil CR	9/9/2005
Pergolide Mesylate	Tablets	0.05 mg, 0.25 mg and 1 mg	Permax
Perindopril Erbumine	Tablets	2 mg, 4 mg and 8 mg	Aceon	6/6/2006
Pioglitazone Hydrochloride	Tablets	15 mg, 30 mg and 45 mg	Actos
Polyethylene Glycol 3350	Powder for Oral Solution	17g/Scoopful	Miralax
Potassium Chloride	Extended-release Capsules	8 mEq and 10 mEq	Micro K
Potassium Chloride	Extended-release Tablets	10 mEq and 20 mEq	K-Dur
Pramipexole Dihydrochloride	Tablets	0.25 mg	Mirapex	5/27/2005
Pramipexole Dihydrochloride	Tablets	0.125 mg, 0.5 mg, 1 mg and 1.5 mg	Mirapex	6/24/2005
Pravastatin Sodium	Tablets	10 mg, 20 mg, 40 mg and 80 mg	Pravachol
Pravastatin Sodium	Tablets	30 mg	Pravachol	6/1/2005
Prazosin Hydrochloride	Capsules	1 mg, 2 mg and 5 mg	Minipress
Prednisolone Sodium Phosphate	Oral Solution	5 mg(base)/ 5 mL and 15 mg (base)/ 5 mL	Pediapred
Propafenone	Extended-release Capsules	325 mg	Rythmol SR	11/07/2006
Propafenone Hydrochloride	Extended-release Capsules	225 mg and 425 mg	Rythmol SR	10/11/2006
Propofol	Injection	10 mg/mL ; 20 mL, 50 mL and 100 mL vials and 20 mL syringe	Diprivan
Propranolol Hydrochloride	Extended-release Capsules	60 mg, 80 mg, 120 mg and 160 mg	Inderal LA
Quetiapine Fumarate	Tablets	25 mg	Seroquel	8/12/2005
Quetiapine Fumarate	Tablets	50 mg, 150 mg and 400 mg	Seroquel	2/12/2007
Quetiapine Fumarate	Tablets	100 mg, 200 mg and 300 mg	Seroquel	2/21/2006
Quinapril Hydrochloride	Tablets	5 mg, 10 mg, 20 mg and 40 mg	Accupril
Quinapril Hydrochloride/ Hydrochlorothiazide	Tablets	10 mg/12.5 mg, 20 mg/12.5 mg and 20mg/25 mg	Accuretic
Rabeprazole Sodium	Delayed-release Tablets	20 mg	Aciphex
Raloxifene Hydrochloride	Tablets	60 mg	Evista
Ramipril	Capsules	1.25 mg, 2.5 mg, 5 mg and 10 mg	Altace
Ranitidine	Capsules	150 mg and 300 mg	Zantac
Ranitidine	Injection	25 mg/mL, 2 mL and 6 mL and 40 mL vials	Zantac
Ranitidine	Oral Solution	15 mg/mL	Zantac
Ranitidine	Tablets	75 mg, 150 mg and 300 mg	Zantac
Repaglinide	Tablets	0.5 mg, 1 mg and 2 mg	Prandin	2/10/2005
Ribavirin	Capsules	200 mg	Rebetol
Risedronate Sodium	Tablets	5 mg, 30 mg and 35 mg	Actonel	4/23/2004
Risperidone	Oral Solution	1 mg/mL	Risperdal
Risperidone	Tablets	0.25 mg, 1 mg, 2 mg, 3 mg and 4 mg	Risperdal
Risperidone	Orally Disintegrating Tablets	0.25 mg	Risperdal	6/27/2005
Risperidone	Orally Disintegrating Tablets	0.5 mg, 1 mg and 2 mg	Risperdal
Risperidone	Orally Disintegrating Tablets	3 mg and 4 mg	Risperdal	9/5/2006
Rivastigmine Tartrate	Capsules	1.5 mg, 3 mg, 4.5 mg and 6 mg	Exelon	4/21/2004
Rivastigmine Tartrate	Oral Solution	2 mg/mL	Exelon	11/5/2004
Rizatriptan Benzoate	Tablets	5 mg and 10 mg	Maxalt	9/2/2004
Rizatriptan Benzoate	Orally Disintegrating Tablets	5 mg and 10 mg	Maxalt-MLT	2/17/2006
Rofecoxib	Tablets	12.5 mg, 25 mg and 50 mg	Vioxx
Ropinirole Hydrochloride	Tablets	0.25 mg, 0.5 mg, 1 mg and 2 mg	Requip	12/22/2004
Ropinirole Hydrochloride	Tablets	3 mg, 4 mg and 5 mg	Requip	2/4/2005
Ropivacaine Hydrochloride	Injection	2 mg/mL, 5 mg/mL and 10 mg/mL, 20 mL, 30 mL and 20 mL vials	Naropin	11/13/2006
Rosiglitazone Maleate	Tablets	2 mg, 4 mg and 8 mg	Avandia
Rosiglitazone Maleate and Metformin Hydrochloride	Tablets	1 mg/ 500 mg, 2 mg/ 500mg, 4 mg/ 500 mg, 2 mg/ 1000 mg and 4 mg/ 1000 mg	Avandamet	10/22/2004
Sertraline Hydrochloride	Oral Concentrate	20 mg/mL	Zoloft
Sertraline Hydrochloride	Tablets	25 mg, 50 mg and 100 mg	Zoloft
Sertraline Hydrochloride	Tablets	150 mg and 200 mg	Zoloft	11/9/2005
Sevoflurane	Inhalation	100%, 250 mL	Ultane
Sildenafil Citrate	Tablets	25 mg and 50 mg	Viagra	11/19/2004
Sildenafil Citrate	Tablets	100 mg	Viagra	10/25/2004
Silver Sulfadiazine	Cream	1%	Silvadene
Simvastatin	Tablets	5 mg, 10 mg, 20 mg, 40 mg and 80 mg	Zocor
Sumatriptan Succinate	Injection	6 mg/0.5 mL, 0.5 mL vials	Imitrex	10/25/2004
Sumatriptan Succinate	Injection	6 mg/0.5 mL, 0.5 mL (prefilled syringes)	Imitrex	5/9/2006
Sumatriptan Succinate	Tablets	25 mg, 50 mg and 100 mg	Imitrex
Tamoxifen Citrate	Tablets	10 mg and 20 mg	Nolvadex
Tamsulosin Hydrochloride	Capsules	0.4 mg	Flomax	12/20/2004
Telmisartan	Tablets	20 mg, 40 mg and 80 mg	Micardis	12/26/2006
Temazepam	Capsules	7.5 mg	Restoril	11/01/2006
Temozolomide	Capsules	5 mg, 20 mg, 100 mg, and 250 mg	Temodar	3/20/2007
Terazosin Hydrochloride	Capsules	1 mg, 2 mg, 5 mg and 10 mg	Hytrin
Terazosin Hydrochloride	Tablets	1 mg, 2 mg, 5 mg and 10 mg	Hytrin
Terbinafine Hydrochloride	Tablets	250 mg	Lamisil
Terfenadine	Tablets	60 mg	Seldane
Testosterone	Gel	1%	Androgel
Thalidomide	Capsules	50 mg and 100 mg	Thalomid	12/18/2006
Thalidomide	Capsules	200 mg	Thalomid	9/25/2006
Tiagabine Hydrochloride	Tablets	2 mg and 4 mg	Gabitril	2/1/2005
Ticlopidine Hydrochloride	Tablets	250 mg	Ticlid
Timolol Maleate	Ophthalmic Solution	0.25% and 0.5%	Timoptic
Tolterodine Tartrate	Tablets	1 mg and 2 mg	Detrol
Topiramate	Capsules	15 mg and 25 mg	Topamax Sprinkle	9/7/2005
Topiramate	Tablets	25 mg, 100 mg and 200 mg	Topamax	12/26/2001
Topiramate	Tablets	50 mg	Topamax	9/8/2005
Torsemide	Tablets	5 mg, 10 mg, 20 mg, and 100 mg	Demadex
Tramadol Hydrochloride	Tablets	50 mg	Ultram
Tramadol Hydrochloride	Extended-release Tablets	100 mg	Ultram ER	1/8/2007
Tramadol Hydrochloride	Extended-release Tablets	200 mg	Ultram ER	3/28/2007
Trandolapril	Tablets	1 mg, 2 mg and 4 mg	Mavik	10/4/2004
Trazodone Hydrochloride	Tablets	150 mg	Desyrel
Tretinoin	Cream	0.025%, 0.05% and 0.1%	Retin-A
Tretinoin	Gel	0.025%	Retin-A
Triamcinolone Acetonide	Nasal Spray	0.055 mg/Spray	Nasacort AQ	12/29/2005
Triamterene/ Hydrochlorothiazide	Tablets	37.5 mg/25 mg and 75 mg/50 mg	Maxzide
Valacyclovir Hydrochloride	Tablets	500 mg and 1 g	Valtrex
Valganciclovir Hydrochloride	Tablets	450 mg	Valcyte	12/27/2005
Valsartan	Tablets	40 mg, 80 mg, 160 mg and 320 mg	Diovan	12/28/2004
Valsartan and Hydrochlorothiazide	Tablets	80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg	Diovan HCT	12/2/2005
Valsartan and Hydrochlorothiazide	Tablets	320 mg/12.5 mg and 320 mg/25 mg	Diovan HCT	2/7/2007
Venlafaxine Hydrochloride	Extended-release Capsules	37.5 mg, 75 mg and 150 mg	Effexor XR
Venlafaxine Hydrochloride	Tablets	25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg	Effexor	11/03/2005
Vecuronium Bromide	For Injection	10 mg/vial and 20 mg/vial	Norcuron
Verapamil Hydrochloride	Extended-release Capsules	100 mg and 200 mg	Verelan PM	7/20/2006
Verapamil Hydrochloride	Extended-release Capsules	120 mg, 180 mg and 240 mg	Verelan SR
Verapamil Hydrochloride	Extended-release Tablets	180 mg	Isoptin SR
Verapamil Hydrochloride	Extended-release Tablets	240 mg	Covera HS
Verapamil Hydrochloride	Extended-release Capsules	300 mg	Verelan PM	5/19/2006
Vincristine Sulfate	Injection	1 mg/mL, 1 mL, 2 mL and 5 mL vials	Oncovin
Zaleplon	Capsules	5 mg and 10 mg	Sonata	6/21/2005
Zidovudine	Capsules	100 mg	Retrovir
Ziprasidone Hydrochloride	Capsules	20 mg, 40 mg, 60 mg and 80 mg	Geodon	2/7/2005
Zolpidem Tartrate	Extended-release Tablets	6.25 mg	Ambien CR	2/24/2006
Zolpidem Tartrate	Extended-release Tablets	12.5 mg	Ambien CR	1/19/2006

* ANDA withdrawn

Footnote:
¹ OGD discovered an administrative error in the date which appeared on this webpage. As of 2/28/2007, the date appearing on this webpage reflects the correct date for the first valid PIV submission(s).