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U.S. Department of Health and Human Services

Drugs

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Approvals - June 2004

 ANDA NumberGeneric Drug NameApplicantApproval Date
174-124CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG  BARR LABORATORIES, INC.6/9/2004 
275-593CIPROFLOXACIN TABLETS, USP 100 MG, 250 MG, 500 MG, AND 750 MG  DR. REDDY'S LABORATORIES LIMITED6/9/2004 
375-685CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG  MYLAN PHARMACEUTICALS, INC.6/9/2004 
475-747CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG  RANBAXY LABORATORIES LIMITED6/9/2004 
575-817CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG  GENPHARM INC.6/9/2004 
675-928CIPROFLOXACIN OPHTHALMIC SOLUTION, USP 0.3%  NOVEX PHARMA6/9/2004 
775-939CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG  SANDOZ INC.6/9/2004 
876-089CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG  IVAX PHARMACEUTICALS, INC.6/9/2004 
976-126CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG  CARLSBAD TECHNOLOGY, INC.6/9/2004 
1076-136CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG  TEVA PHARMACEUTICALS USA6/9/2004 
1176-138CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG  MARTEC SCIENTIFIC, INC.6/9/2004 
1276-558CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG  HIKMA PHARMACEUTICALS6/9/2004 
1376-593CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG  EON LABS, INC.6/9/2004 
1476-754CIPROFLOXACIN OPHTHALMIC SOLUTION, USP 0.3%  BAUSCH & LOMB, INC.6/9/2004 
1576-794CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG  COBALT PHARMACEUTICALS, INC.6/9/2004 
1676-161DOXAZOSIN MESYLATE TABLETS 1 MG (BASE), 2 MG (BASE), 4 MG (BASE), AND 8 MG (BASE)  CLONMEL HEALTHCARE LTD6/10/2004 
1776-560BUTALBITAL, ACETAMINOPHEN, CAFFEINE & CODEINE PHOSPHATE CAPS 50 MG/325 MG/40 MG/30 MG  ANABOLIC LABORATORIES, INC.6/10/2004 
1876-172METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG  ANDRX PHARMACEUTICALS LLC6/16/2004 
1976-212CARBIDOPA AND LEVODOPA EXTENDED-RELEASE TABLETS 25 MG/100 MG AND 50 MG/200 MG  TORPHARM INC.6/16/2004 
2076-404ADENOSINE INJECTION, USP 3 MG/ML; PACKAGED IN 6 MG/2 ML AND 12 MG/4 ML SINGLE-DOSE VIALS  BEDFORD LABORATORIES6/16/2004 
2176-500ADENOSINE INJECTION, USP 3 MG/ML; PACKAGED IN 6 MG/2 ML SINGLE-DOSE VIALS.  BAXTER HEALTHCARE CORPORATION6/16/2004 
2276-501ADENOSINE INJECTION, USP 3 MG/ML; PACKAGED IN 6 MG/2 ML SINGLE-DOSE SYRINGES  BAXTER HEALTHCARE CORPORATION6/16/2004 
2376-564ADENOSINE 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 
2476-741IBUPROFEN TABLETS (OTC) 100 MG  LNK INTERNATIONAL, INC.6/17/2004 
2576-269METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG  TEVA PHARMACEUTICALS USA6/18/2004 
2676-413METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG  RANBAXY LABORATORIES LIMITED6/18/2004 
2740-519DIMENHYDRINATE INJECTION, USP 50 MG/ML; PACKAGED IN 1 ML AND 10 ML MULTIPLE-DOSE VIALS  AMERICAN PHARMACEUTICAL PARTNERS, INC.6/23/2004 
2840-556HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 10 MG/300 MG  MIKART INC.6/23/2004 
2975-570AMMONIUM LACTATE LOTION 12% (BASE)  CLAY-PARK LABS, INC.6/23/2004 
3076-479ECONAZOLE NITRATE CREAM 1%  CLAY-PARK LABS, INC.6/23/2004 
3176-586FLUOCINONIDE CREAM, USP (EMOLLIENT BASE) 0.05%  ALTANA INC.6/23/2004 
3276-764LEVOTHYROXINE 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 
3365-145CLARITHROMYCIN EXTENDED-RELEASE TABLETS 500 MG  ANDRX PHARMACEUTICALS, LLC6/24/2004 
3476-663CARBIDOPA AND LEVODOPA EXTENDED-RELEASE TABLETS 50 MG/200 MG  KV PHARMACEUTICAL COMPANY6/24/2004 
3576-301LORADATINE TABLETS, USP (OTC) 10 MG  L. PERRIGO COMPANY6/25/2004 
3676-355ALBUTEROL SULFATE INHALATION SOLUTION 0.042% (BASE)  NEPHRON PHARMACEUTICALS CORPORATION6/28/2004 
3776-750PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP 100 MG/500 MG  VINTAGE PHARMACEUTICALS, INC.6/28/2004 
3876-823LITHIUM CARBONATE CAPSULES, USP 150 MG, 300 MG, AND 600 MG  ABLE LABORATORIES, INC.6/29/2004 
3940-545OXYCODONE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/325 MG AND 10 MG/325 MG  MALLINCKRODT, INC.6/30/2004 
4040-550OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/500 MG AND 10 MG/650 MG  MALLINCKRODT, INC.6/30/2004 
4176-758OXYCODONE HYDROCHLORIDE TABLETS, USP 15 MG AND 30 MG  MALLINCKRODT, INC.6/30/2004