| |
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 |
