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Approvals - May 2005

  ANDA Number Generic Drug Name Applicant Approval Date
1 76-379 MIDAZOLAM HYDROCHLORIDE SYRUP, 2 MG (BASE)/ML   PADDOCK LABORATORIES, INC. 5/2/2005 
2 76-474 ESMOLOL HYDROCHLORIDE INJECTION 10 MG/ML; 10 ML VIALS   PHARMAFORCE, INC. 5/2/2005 
3 76-573 ESMOLOL HYDROCHLORIDE INJECTION 10 MG/ML; 10 ML VIALS   AMERICAN PHARMACEUTICAL PARTNERS, INC. 5/2/2005 
4 77-147 CLONAZEPAM TABLETS USP 0.5 MG, 1 MG, AND 2 MG   KALI LABORATORIES, INC. 5/2/2005 
5 65-183 NYSTATIN TOPICAL POWDER USP, 100,000 UNITS/GRAM   UPSHER-SMITH LABORATORIES, INC. 5/3/2005 
6 65-204 CEFTRIAXONE FOR INJECTION USP, 1 G AND 2 G VIALS   SANDOZ, INC. 5/3/2005 
7 77-071 FLUMAZENIL INJECTION USP, 0.1 MG/ML; 5 ML AND 10 ML VIALS   SABEX 2002 INC. 5/3/2005 
8 65-169 CEFTRIAXONE FOR INJECTION USP, 250 MG, 500 MG, 1 G, AND 2 G VIALS   SANDOZ, INC. 5/9/2005 
9 76-291 IPRATROPIUM BROMIDE INHALATION SOLUTION, 0.02%; 0.5 MG/2.5 ML VIALS   BREATH LIMITED 5/9/2005 
10 65-103 DOXYCYCLINE HYCLATE CAPSULES USP, 20 MG   WEST-WARD PHARMACEUTICAL CORP. 5/13/2005 
11 65-134 DOXYCYCLINE HYCLATE TABLETS USP, 20 MG   MUTUAL PHARMACEUTICAL COMPANY, INC. 5/13/2005 
12 65-163 DOXYCYCLINE HYCLATE TABLETS USP, 20 MG   IVAX PHARMACEUTICALS, INC. 5/13/2005 
13 65-182 DOXYCYCLINE HYCLATE TABLETS USP, 20 MG   COREPHARMA LLC 5/13/2005 
14 76-433 FENOFIBRATE TABLETS, 54 MG AND 160 MG   TEVA PHARMACEUTICALS USA 5/13/2005 
15 65-168 CEFTRIAXONE FOR INJECTION USP, 10 G/VIAL (PHARMACY BULK PACKAGE)   SANDOZ, INC. 5/17/2005 
16 76-906 FOSINOPRIL SODIUM TABLETS, 10 MG, 20 MG, AND 40 MG   APOTEX INC. 5/17/2005 
17 77-024 CILOSTAZOL TABLETS, 50 MG AND 100 MG   ROXANE LABORATORIES, INC. 5/17/2005 
18 65-154 CLARITHROMYCIN EXTENDED-RELEASE TABLETS, 500 MG   TEVA PHARMACEUTICALS USA 5/18/2005 
19 76-251 FLUOXETINE CAPSULES USP, 40 MG   BARR LABORATORIES, INC. 5/18/2005 
20 77-077 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP, AND FERROUS FUMARATE TABLETS, 1 MG/0.02 MG/75 MG   ANDRX PHARMACEUTICALS, LLC 5/20/2005 
21 76-785 ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL TABLETS USP, 1 MG/35 MCG; PACKAGED IN 28-DAY REGIMENS   BARR LABORATORIES, INC. 5/23/2005 
22 76-982 PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION, 5 MG (BASE)/5 ML   KV PHARMACEUTICAL COMPANY 5/24/2005 
23 76-988 PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION, 15 MG (BASE)/5 ML   KV PHARMACEUTICAL COMPANY 5/24/2005 
24 40-574 HYDROXYZINE HYDROCHLORIDE TABLETS USP, 25 MG   VINTAGE PHARMACEUTICALS, LLC 5/27/2005 
25 40-579 HYDROXYZINE HYDROCHLORIDE TABLETS USP, 10 MG   VINTAGE PHARMACEUTICALS, LLC 5/27/2005 
26 40-580 HYDROXYZINE HYDROCHLORIDE TABLETS USP, 50 MG   VINTAGE PHARMACEUTICALS, LLC 5/27/2005 
27 65-137 CLARITHROMYCIN TABLETS USP, 250 MG AND 500 MG   IVAX PHARMACEUTICALS, INC. 5/31/2005 
28 65-155 CLARITHROMYCIN TABLETS USP, 250 MG AND 500 MG   TEVA PHARMACEUTICALS USA 5/31/2005 
29 76-894 TORSEMIDE TABLETS, 5 MG, 10 MG, 20 MG, AND 100 MG   APOTEX INC. 5/31/2005 
30 77-174 FOSCARNET SODIUM INJECTION, 24 MG/ML; 250 ML AND 500 ML BOTTLES   PHARMAFORCE, INC. 5/31/2005 

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Date created: June 15, 2005

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