|
ANDA Number |
Drug Name |
Applicant |
Approval Date |
1 |
75-689 |
HALOPERIDOL INJECTION USP, 5 MG (BASE)/ML 5 MG (BASE)/ML |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
3/9/01 |
2 |
75-751 |
DESONIDE OINTMENT 0.05% |
ALTANA, INC. |
3/12/01 |
3 |
75-898 |
FLUVOXAMINE MALEATE TABLETS 25 MG 50 MG 100 MG |
ZENITH GOLDLINE PHARMACEUTICALS, INC. |
3/12/01 |
4 |
40-388 |
HYDRALAZINE HYDROCHLORIDE INJECTION, USP 20 MG/ML |
AMERICAN PHARMACEUTICAL PARTNERS INC. |
3/13/01 |
5 |
65-028 |
RIFAMPIN CAPSULES, USP 150 MG 300 MG |
APPLIED ANALYTICAL INDUSTRIES, INC. |
3/14/01 |
6 |
40-385 |
METHOTREXATE TABLETS, USP 5 MG 7.5 MG 10 MG 15 MG |
BARR LABORATORIES, INC. |
3/21/01 |
7 |
75-178 |
ENALAPRIL MALEATE TABLETS, USP 2.5 MG 5 MG 10 MG 20 MG |
TORPHARM |
3/23/01 |
8 |
75-618 |
BUTALBITAL, ACETAMINOPHEN & CAFFEINE WITH CODEINE PHOS. CAPS 50 MG/325 MG/40 MG/30 MG |
WEST-WARD PHARMACEUTICAL CORP. |
3/23/01 |
9 |
40-411 |
METHIMAZOLE TABLETS, USP 5 MG 10 MG |
EON LABS MANUFACTURING, INC. |
3/27/01 |
10 |
75-297 |
PACLITAXEL INJECTION 6 MG/ML (30 MG/5 ML) (100 MG/16.7 ML) AND 150 MG/25 ML) |
ZENITH GOLDLINE PHARMACEUTICALS, INC. |
3/27/01 |
11 |
74-253 |
BUSPIRONE HYDROCHLORIDE TABLETS, USP 5 MG, 10 MG 10 MG |
DANBURY PHARMACAL, INC. |
3/28/01 |
12 |
75-272 |
BUSPIRONE HYDROCHLORIDE TABLETS, USP 15 MG |
MYLAN PHARMACEUTICALS, INC. |
3/28/01 |
13 |
75-441 |
IPRATROPIUM BROMIDE INHALATION SOLUTION 0.02% |
NOVEX PHARMA |
3/28/01 |
14 |
75-467 |
BUSPIRONE HYDROCHLORIDE TABLETS, USP 7.5 MG |
PAR PHARMACEUTICAL, INC. |
3/28/01 |
15 |
75-627 |
ACYCLOVIR INJECTION 50 MG/ML; (500 MG/10 ML) AND (1 G/20 ML). |
GENSIA SICOR PHARMACEUTICALS, INC. |
3/28/01 |
16 |
40-404 |
METHYLPHENIDATE HYDROCHLORIDE TABLETS, USP 5 MG 10 MG 20 MG |
ABLE LABORATORIES, INC. |
3/29/01 |
17 |
75-567 |
LEVOCARNITINE INJECTION, USP 200 MG/ML; (500 MG/2.5 ML), AND (1 G/5 ML) VIALS |
BEDFORD LABORATORIES |
3/29/01 |
18 |
75-881 |
LEVOCARNITINE INJECTION, USP 200 MG/ML (500 MG/2.5 ML) (1 G/5 ML) (2.5 G/12.5 ML) VIALS |
GENSIA SICOR PHARMACEUTICALS, INC. |
3/29/01 |
19 |
75-424 |
AMIODARONE HYDROCHLORIDE TABLETS 200 MG |
TARO PHARMACEUTICAL INDUSTRIES, LTD. |
3/30/01 |
20 |
75-726 |
PEMOLINE TABLETS 18.75 MG 37.5 MG 75 MG |
MALLINCKRODT, INC. |
3/30/01 |