| |
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
| 1 |
76-721 |
MEGESTROL ACETATE ORAL SUSPENSION, USP 40
MG/ML |
MORTON GROVE PHARMACEUTICALS, INC. |
11/1/2004 |
| 2 |
76-762 |
LOXAPINE CAPSULES, USP 5 MG, 10 MG, 25
MG, AND 50 MG |
MYLAN PHARMACEUTICALS, INC. |
11/1/2004 |
| 3 |
75-896 |
FELODIPINE EXTENDED-RELEASE TABLETS, USP
2.5 MG, 5 MG, AND 10 MG |
MUTUAL PHARMACEUTICAL COMPANY, INC. |
11/2/2004 |
| 4 |
76-725 |
MIDODRINE HYDROCHLORIDE TABLETS 2.5 MG, 5
MG, AND 10 MG |
UPSHER-SMITH LABORATORIES |
11/3/2004 |
| 5 |
76-896 |
CIPROFLOXACIN TABLETS, USP 250 MG, 500
MG, AND 750 MG |
APOTEX INC. |
11/4/2004 |
| 6 |
77-037 |
CITALOPRAM HYDROBROMIDE TABLETS 10 MG
(BASE), 20 MG (BASE), AND 40 MG (BASE) |
ALPHAPHARM PTY LTD. |
11/5/2004 |
| 7 |
77-042 |
CITALOPRAM HYDROBROMIDE TABLETS 10 MG
(BASE), 20 MG (BASE), AND 40 MG (BASE) |
KALI LABORATORIES, INC. |
11/5/2004 |
| 8 |
77-044 |
CITALOPRAM HYDROBROMIDE TABLETS 10 MG
(BASE), 20 MG (BASE), AND 40 MG (BASE) |
WATSON LABORATORIES, INC. |
11/5/2004 |
| 9 |
40-541 |
SODIUM TETRADECYL SULFATE INJECTION 1%
(10 MG/ML) AND 3% (30 MG/ML) PACKAGED IN 2 ML VIALS |
BIONICHE PHARMA U.S.A., INC. |
11/12/2004 |
| 10 |
75-436 |
PACLITAXEL INJECTION, USP 6 MG/ML;
PACKAGED IN 30 MG/5 ML AND 100 MG/16.7 ML MULTIPLE-DOSE
VIALS |
SUPERGEN, INC. |
11/12/2004 |
| 11 |
77-032 |
CITALOPRAM HYDROBROMIDE TABLETS 10 MG
(BASE), 20 MG (BASE), AND 40 MG (BASE) |
CARACO PHARMACEUTICAL LABORATORIES, LTD. |
11/12/2004 |
| 12 |
76-150 |
LORAZEPAM INJECTION, USP 2 MG/ML |
INTERNATIONAL MEDICATION SYSTEMS, LTD. |
11/15/2004 |
| 13 |
76-602 |
CARBOPLATIN FOR INJECTION, USP 50 MG, 150
MG, AND 450 MG SINGLE-DOSE VIALS |
PLIVA - LACHEMA A.S. |
11/16/2004 |
| 14 |
76-609 |
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
TABLETS, USP 100 MG/650 MG |
ANDRX PHARMACEUTICALS, LLC |
11/16/2004 |
| 15 |
76-746 |
PILOCARPINE HYDROCHLORIDE TABLETS 5 MG |
COREPHARMA, LLC |
11/16/2004 |
| 16 |
77-048 |
CITALOPRAM HYDROBROMIDE TABLETS 10 MG
(BASE), 20 MG (BASE), AND 40 MG (BASE) |
IVAX PHARMACEUTICALS, INC. |
11/16/2004 |
| 17 |
76-625 |
LEVONORGESTREL AND ETHINYL ESTRADIOL
TABLETS, USP 0.1 MG/0.02 MG (28-DAY REGIMEN) |
WATSON LABORATORIES, INC. |
11/18/2004 |
| 18 |
74-764 |
RANITIDINE INJECTION, USP 25 MG
(BASE)/ML; PACKAGED IN 50 MG (BASE)/2 ML AND 150 MG
(BASE)/6 ML MULTIPLE DOSE VIALS |
BEDFORD LABORATORIES |
11/19/2004 |
| 19 |
76-731 |
GLYBURIDE AND METFORMIN HYDROCHLORIDE
TABLETS 1.25 MG/250 MG, 2.5 MG/500 MG, AND 5 MG/500 MG |
COREPHARMA LLC |
11/19/2004 |
| 20 |
76-795 |
LITHIUM CARBONATE CAPSULES, USP 300 MG |
APOTEX INC. |
11/22/2004 |
| 21 |
77-019 |
CILOSTAZOL TABLETS 50 MG AND 100 MG |
ALPHAPHARM PTY, LTD. |
11/23/2004 |
| 22 |
77-021 |
CILOSTAZOL TABLETS 100 MG |
EON LABS, INC. |
11/23/2004 |
| 23 |
77-022 |
CILOSTAZOL TABLETS 100 MG |
COREPHARMA, LLC |
11/23/2004 |
| 24 |
77-041 |
CITALOPRAM HYDROBROMIDE TABLETS 10 MG
(BASE), 20 MG (BASE), AND 40 MG (BASE) |
ROXANE LABORATORIES, INC. |
11/23/2004 |
| 25 |
77-059 |
CARBOPLATIN INJECTION 10 MG/ML; PACKAGED
IN 600 MG/60 ML SINGLE-DOSE VIALS |
MAYNE PHARMA (USA) INC. |
11/23/2004 |
| 26 |
77-027 |
CILOSTAZOL TABLETS 50 MG AND 100 MG |
TEVA PHARMACEUTICALS USA |
11/24/2004 |
| 27 |
77-046 |
CITALOPRAM HYDROBROMIDE TABLETS 10 MG
(BASE), 20 MG (BASE), AND 40 MG (BASE) |
APOTEX INC. |
11/24/2004 |
| 28 |
77-028 |
CILOSTAZOL TABLETS 100 MG |
AMIDE PHARMACEUTICAL, INC. |
11/26/2004 |
