| |
ANDA Number |
Drug Name |
Applicant |
Approval Date |
| 1 |
75-839 |
MINOXIDIL TOPICAL SOLUTION, USP (FOR MEN) 5% (OTC) |
NOVEX PHARMA |
10/1/01 |
| 2 |
75-843 |
OXAPROZIN TABLETS 600 MG |
PUREPAC PHARMACEUTICAL CO. |
10/3/01 |
| 3 |
64-163 |
GENTAMICIN SULFATE OPHTHALMIC SOLUTION, USP 0.3% (BASE) |
AKORN NEW JERSEY, INC. |
10/12/01 |
| 4 |
75-765 |
CALCITRIOL CAPSULES 0.25 MCG AND 0.5 MCG |
TEVA PHARMACEUTICALS USA |
10/12/01 |
| 5 |
75-515 |
SOTALOL HYDROCHLORIDE TABLETS 80 MG, 120 MG, 160 MG, AND 240 MG |
MUTUAL PHARMACEUTICAL COMPANY |
10/15/01 |
| 6 |
75-835 |
IPRATROPIUM BROMIDE INHALATION SOLUTION 0.02% |
BAUSCH & LOMB PHARMACEUTICALS, INC. |
10/15/01 |
| 7 |
75-909 |
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USP 5 MG/12.5 MG AND 10 MG/25 MG |
DR. REDDY'S LABORATORIES, LTD. |
10/15/01 |
| 8 |
75-950 |
FLUVOXAMINE MALEATE TABLETS 50 MG AND 100 MG |
GENPHARM INC. |
10/15/01 |
| 9 |
65-042 |
BLEOMYCIN FOR INJECTION, USP 15 UNITS (BASE)/VIAL AND 30 UNITS (BASE)/VIAL |
BEDFORD LABORATORIES |
10/17/01 |
| 10 |
75-940 |
DACARBAZINE FOR INJECTION, USP 200 MG/VIAL |
FAULDING PHARMACEUTICAL CO. |
10/18/01 |
| 11 |
40-423 |
PREDNISOLONE SYRUP, USP 5 MG/5 ML |
KV PHARMACEUTICAL COMPANY |
10/22/01 |
| 12 |
75-695 |
BUTORPHANOL TARTRATE INJECTION, USP (PRESERVATIVE-FREE) 1 MG/ML (1 ML VIAL); 2 MG/ML (1 ML & 2 ML VIALS) |
APOTEX CORP. |
10/23/01 |
| 13 |
75-697 |
BUTORPHANOL TARTRATE INJECTION, USP 2 MG/ML (MULTIPLE-DOSE VIAL) |
APOTEX CORP. |
10/23/01 |
| 14 |
75-659 |
NIFEDIPINE EXTENDED-RELEASE TABLETS 60 MG |
ELAN PHARMACEUTICAL RESEARCH CORPORATION |
10/26/01 |
| 15 |
76-112 |
IBUPROFEN TABLETS, USP 400 MG, 600 MG, AND 800 MG |
DR. REDDY'S LABORATORIES, LTD. |
10/31/01 |
