| |
ANDA Number |
Drug Name |
Applicant |
Approval Date |
| 1 |
65-026 |
TOBRAMYCIN OPHTHALMIC SOLUTION 0.3% |
ALTANA INC. |
9/11/01 |
| 2 |
75-558 |
VECURONIUM BROMIDE FOR INJECTION 4 MG/AMPUL |
ABBOTT LABORATORIES |
9/11/01 |
| 3 |
75-209 |
LORATADINE TABLETS 10 MG |
GENEVA PHARMACEUTICALS, INC. |
9/13/01 |
| 4 |
75-650 |
FAMOTIDINE TABLETS, USP 20 MG, AND 40 MG |
PUREPAC PHARMACEUTICAL CO. |
9/14/01 |
| 5 |
65-047 |
CEFAZOLIN FOR INJECTION, USP 500 MG/VIAL, 1 G/VIAL, AND 1 G/100 ML INFUSION VIAL. |
HIKMA FARMACEUTICA (PORTUGAL), LDA. |
9/18/01 |
| 6 |
75-298 |
FLUTAMIDE CAPSULES USP 125 MG |
TEVA PHARMACEUTICALS USA |
9/18/01 |
| 7 |
75-624 |
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USP 5 MG/12.5 MG; AND 10 MG/25 MG |
MYLAN PHARMACEUTICALS, INC. |
9/18/01 |
| 8 |
75-727 |
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS 5 MG/ 12.5 MG; AND 10 MG/ 25 MG |
TEVA PHARMACEUTICALS USA |
9/18/01 |
| 9 |
75-788 |
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS USP 5 MG/ 12.5 MG; AND 10 MG/ 25 MG |
TARO PHARMACEUTICAL INDUSTRIES LTD |
9/18/01 |
| 10 |
75-818 |
FLUTAMIDE CAPSULES USP 125 MG |
EON LABS MANUFACTURING, INC. |
9/18/01 |
| 11 |
75-820 |
FLUTAMIDE CAPSULES USP 125 MG |
BARR LABORATORIES, INC. |
9/18/01 |
| 12 |
75-635 |
ETOPOSIDE CAPSULES, USP 50 MG |
GENPHARM INC. |
9/19/01 |
| 13 |
75-780 |
FLUTAMIDE CAPSULES, USP 125 MG |
ZENITH GOLDLINE PHARMACEUTICALS, INC. |
9/19/01 |
| 14 |
76-116 |
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USP 5 MG/12.5 MG, AND 10 MG/25 MG |
EON LABS MANUFACTURING, INC. |
9/19/01 |
| 15 |
75-698 |
THIOTEPA FOR INJECTION, USP 15 MG/VIAL |
AAI PHARMA |
9/20/01 |
| 16 |
75-562 |
IPRATROPIUM BROMIDE INHALATION SOLUTION 0.02% (0.5 MG/2.5 ML VIAL) |
NEPHRON PHARMACEUTICALS CORPORATION |
9/27/01 |
| 17 |
76-121 |
LITHIUM CARBONATE CAPSULES, USP 300 MG |
ABLE LABORATORIES, INC. |
9/27/01 |
