Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail
-

Approvals - June 2004

  ANDA Number Generic Drug Name Applicant Approval Date
1 74-124 CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG   BARR LABORATORIES, INC. 6/9/2004 
2 75-593 CIPROFLOXACIN TABLETS, USP 100 MG, 250 MG, 500 MG, AND 750 MG   DR. REDDY'S LABORATORIES LIMITED 6/9/2004 
3 75-685 CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG   MYLAN PHARMACEUTICALS, INC. 6/9/2004 
4 75-747 CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG   RANBAXY LABORATORIES LIMITED 6/9/2004 
5 75-817 CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG   GENPHARM INC. 6/9/2004 
6 75-928 CIPROFLOXACIN OPHTHALMIC SOLUTION, USP 0.3%   NOVEX PHARMA 6/9/2004 
7 75-939 CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG   SANDOZ INC. 6/9/2004 
8 76-089 CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG   IVAX PHARMACEUTICALS, INC. 6/9/2004 
9 76-126 CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG   CARLSBAD TECHNOLOGY, INC. 6/9/2004 
10 76-136 CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG   TEVA PHARMACEUTICALS USA 6/9/2004 
11 76-138 CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG   MARTEC SCIENTIFIC, INC. 6/9/2004 
12 76-558 CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG   HIKMA PHARMACEUTICALS 6/9/2004 
13 76-593 CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG   EON LABS, INC. 6/9/2004 
14 76-754 CIPROFLOXACIN OPHTHALMIC SOLUTION, USP 0.3%   BAUSCH & LOMB, INC. 6/9/2004 
15 76-794 CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG   COBALT PHARMACEUTICALS, INC. 6/9/2004 
16 76-161 DOXAZOSIN MESYLATE TABLETS 1 MG (BASE), 2 MG (BASE), 4 MG (BASE), AND 8 MG (BASE)   CLONMEL HEALTHCARE LTD 6/10/2004 
17 76-560 BUTALBITAL, ACETAMINOPHEN, CAFFEINE & CODEINE PHOSPHATE CAPS 50 MG/325 MG/40 MG/30 MG   ANABOLIC LABORATORIES, INC. 6/10/2004 
18 76-172 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG   ANDRX PHARMACEUTICALS LLC 6/16/2004 
19 76-212 CARBIDOPA AND LEVODOPA EXTENDED-RELEASE TABLETS 25 MG/100 MG AND 50 MG/200 MG   TORPHARM INC. 6/16/2004 
20 76-404 ADENOSINE INJECTION, USP 3 MG/ML; PACKAGED IN 6 MG/2 ML AND 12 MG/4 ML SINGLE-DOSE VIALS   BEDFORD LABORATORIES 6/16/2004 
21 76-500 ADENOSINE INJECTION, USP 3 MG/ML; PACKAGED IN 6 MG/2 ML SINGLE-DOSE VIALS.   BAXTER HEALTHCARE CORPORATION 6/16/2004 
22 76-501 ADENOSINE INJECTION, USP 3 MG/ML; PACKAGED IN 6 MG/2 ML SINGLE-DOSE SYRINGES   BAXTER HEALTHCARE CORPORATION 6/16/2004 
23 76-564 ADENOSINE INJECTION, USP 3 MG/ML; PACKAGED IN 6 MG/2 ML, AND 12 MG/4 ML SINGLE- DOSE VIALS   SICOR PHARMACEUTICALS, INC. 6/16/2004 
24 76-741 IBUPROFEN TABLETS (OTC) 100 MG   LNK INTERNATIONAL, INC. 6/17/2004 
25 76-269 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG   TEVA PHARMACEUTICALS USA 6/18/2004 
26 76-413 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG   RANBAXY LABORATORIES LIMITED 6/18/2004 
27 40-519 DIMENHYDRINATE INJECTION, USP 50 MG/ML; PACKAGED IN 1 ML AND 10 ML MULTIPLE-DOSE VIALS   AMERICAN PHARMACEUTICAL PARTNERS, INC. 6/23/2004 
28 40-556 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 10 MG/300 MG   MIKART INC. 6/23/2004 
29 75-570 AMMONIUM LACTATE LOTION 12% (BASE)   CLAY-PARK LABS, INC. 6/23/2004 
30 76-479 ECONAZOLE NITRATE CREAM 1%   CLAY-PARK LABS, INC. 6/23/2004 
31 76-586 FLUOCINONIDE CREAM, USP (EMOLLIENT BASE) 0.05%   ALTANA INC. 6/23/2004 
32 76-764 LEVOTHYROXINE SODIUM TABLETS, USP 0.025 MG, 0.05 MG, 0.075 MG, 0.088 MG, 0.1 MG, 0.112 MG, 0.125 MG, 0.15 MG, 0.175 MG, 0.2 MG, AND 0.3 MG   MYLAN PHARMACEUTICALS, INC. 6/23/2004 
33 65-145 CLARITHROMYCIN EXTENDED-RELEASE TABLETS 500 MG   ANDRX PHARMACEUTICALS, LLC 6/24/2004 
34 76-663 CARBIDOPA AND LEVODOPA EXTENDED-RELEASE TABLETS 50 MG/200 MG   KV PHARMACEUTICAL COMPANY 6/24/2004 
35 76-301 LORADATINE TABLETS, USP (OTC) 10 MG   L. PERRIGO COMPANY 6/25/2004 
36 76-355 ALBUTEROL SULFATE INHALATION SOLUTION 0.042% (BASE)   NEPHRON PHARMACEUTICALS CORPORATION 6/28/2004 
37 76-750 PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP 100 MG/500 MG   VINTAGE PHARMACEUTICALS, INC. 6/28/2004 
38 76-823 LITHIUM CARBONATE CAPSULES, USP 150 MG, 300 MG, AND 600 MG   ABLE LABORATORIES, INC. 6/29/2004 
39 40-545 OXYCODONE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/325 MG AND 10 MG/325 MG   MALLINCKRODT, INC. 6/30/2004 
40 40-550 OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/500 MG AND 10 MG/650 MG   MALLINCKRODT, INC. 6/30/2004 
41 76-758 OXYCODONE HYDROCHLORIDE TABLETS, USP 15 MG AND 30 MG   MALLINCKRODT, INC. 6/30/2004 

 

-
-