| |
ANDA Number |
Drug Name |
Applicant |
Approval Date |
| 1 |
75-916 |
RIMANTADINE HYDROCHLORIDE TABLETS 100 MG |
COREPHARMA LLC |
11/2/01 |
| 2 |
75-682 |
IBUPROFEN TABLETS, USP 400 MG, 600 MG, AND 800 MG |
BASF CORPORATION |
11/14/01 |
| 3 |
75-347 |
OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG, 20 MG, AND 40 MG |
ANDRX PHARMACEUTICALS, INC. |
11/16/01 |
| 4 |
65-034 |
DAUNORUBICIN HYDROCHLORIDE INJECTION 5 MG (BASE)/ML; 4 ML SINGLE-DOSE VIALS |
SUPERGEN, INC. |
11/20/01 |
| 5 |
76-117 |
IBUPROFEN TABLETS, USP (OTC) 200 MG |
DR. REDDY'S LABORATORIES LIMITED |
11/20/01 |
| 6 |
75-569 |
THALLOUS CHLORIDE TL-201 INJECTION, USP 1 mCi/ML |
MOUNT SINAI MEDICAL CENTER |
11/21/01 |
| 7 |
75-749 |
DILTIAZEM HYDROCHLORIDE INJECTION 5 MG/ML, PACKAGED IN 25 MG/5 ML SYRINGE AND 50 MG/10 ML DILUTE-A-JET SYRINGE |
INTERNATIONAL MEDICATION SYSTEMS LIMITED |
11/21/01 |
| 8 |
75-915 |
TIOCONAZOLE VAGINAL OINTMENT 6.5% (OTC) |
L. PERRIGO COMPANY |
11/21/01 |
| 9 |
40-434 |
OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/325 MG, AND 10 MG/325 MG |
ENDO PHARMACEUTICALS, INC. |
11/23/01 |
| 10 |
75-870 |
FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML (20 MG/2 ML SINGLE-DOSE VIAL) |
ABBOTT LABORATORIES |
11/23/01 |
| 11 |
75-905 |
FAMOTIDINE INJECTION 10 MG/ML; PACKAGED IN 4 ML & 20 ML MULTIPLE-DOSE VIALS |
ABBOTT LABORATORIES |
11/23/01 |
| 12 |
75-794 |
ACETAMINOPHEN, ASPIRIN, AND CAFFEINE TABLETS, USP 250 MG/250 MG/65 MG, RESPECTIVELY (OTC) |
L. PERRIGO COMPANY |
11/26/01 |
| 13 |
76-057 |
ETHAMBUTOL HYDROCHLORIDE TABLETS, USP 400 MG |
BARR LABORATORIES, INC. |
11/26/01 |
| 14 |
75-404 |
FAMOTIDINE TABLETS, USP (OTC) 10 MG |
DANBURY PHARMACAL, INC. |
11/28/01 |
| 15 |
75-721 |
LEUPROLIDE ACETATE INJECTION 1 MG/0.2 ML (2.8 ML MULTIPLE-DOSE VIALS) |
GENZYME CORPORATION |
11/29/01 |
| 16 |
75-998 |
PROPAFENONE HYDROCHLORIDE TABLETS 150 MG, 225 MG, AND 300 MG |
MUTUAL PHARMACEUTICAL COMPANY |
11/29/01 |
| 17 |
75-231 |
BUTALBITAL, ASPIRIN, CAFFEINE, & CODEINE PHOSPHATE CAPS, USP 50 MG/325 MG/40 MG/30 MG |
ANABOLIC, INC. |
11/30/01 |
| 18 |
75-829 |
ETODOLAC EXTENDED-RELEASE TABLETS 400 MG 500 MG |
ANDRX PHARMACEUTICALS, L.L.C. |
11/30/01 |
| 19 |
75-840 |
NORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP 21-DAY & 28-DAY REGIMENS; 0.3 MG/0.03 MG NOTE:28-DAY REGIMEN ALSO CONTAINS 7 INERT TABLETS. |
DURAMED PHARMACEUTICALS, INC. |
11/30/01 |
