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Tentative Approvals - December 2004

Tentative Approvals - December 2004

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 76-788 MOMETASONE FUROATE TOPICAL SOLUTION, USP (LOTION) 0.1%   TARO PHARMACEUTICALS USA, INC. 12/3/2004 
2 76-679 MOMETASONE FUROATE CREAM, USP 0.1%   TARO PHARMACEUTICALS USA, INC. 12/3/2004 
3 75-719 SERTRALINE HYDROCHLORIDE TABLETS 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)   IVAX PHARMACEUTICALS, INC. 12/9/2004 
4 76-605 GABAPENTIN TABLETS 600 MG AND 800 MG   RANBAXYLABORATORIES LIMITED 12/9/2004 
5 76-610 OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS 10 MG, 20 MG, AND 40 MG   TEVA PHARMACEUTICALS USA 12/9/2004 
6 76-864 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 750 MG   TEVA PHARMACEUTICALS USA 12/13/2004 
7 76-672 GABAPENTIN ORAL SOLUTION 250 MG/5 ML   TARO PHARMACEUTICAL INDUSTRIES LTD. 12/14/2004 
8 76-327 TOPIRAMATE TABLETS 25 MG, 100 MG, AND 200 MG RANBAXY LABORATORIES LIMITED 12/15/2004 
9 76-747 ROSIGLITAZONE MALEATE TABLETS 2 MG (BASE), 4 MG (BASE), AND 8 MG (BASE)   TEVA PHARMACEUTICALS USA 12/20/2004 
10 76-960 ONDANSETRON HYDROCHLORIDE ORAL SOLUTION 4 MG (BASE)/5 ML   ROXANE LABORATORIES, INC. 12/20/2004 
11 76-719 AMLODIPINE BESYLATE TABLETS 2.5 MG (BASE), 5 MG (BASE), AND 10 MG (BASE)   APOTEX INC. 12/29/2004 

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Date created: January 6, 2005

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YOUR CONTACT INFORMATION
First Name: *
Last Name: *
E-mail Address: *
Address:
City:
State: *
Zipcode:
Phone: -- xtn

CASE INFORMATION
Why Was Avandia Prescribed?: *
What Dosage, in Milligrams?:
How Frequently Was Avandia Taken?:
Date Patient Began Taking Avandia:

Stopped Taking Avandia:

What Symptoms Were Experienced?: *
Heart Attack
Stroke
Heart Failure

 Death
Other
PPH
If "Other", Please Describe:
How Long Was it From the Last Dose to the Problems Appearing?:
    Within 1 Day 2 Days 3 Days
    More Than 3 Days Don't Know
Questions/Comments:
This form is secure and encrypted. More information about secure forms and your privacy here.