| |
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
| 1 |
76-770 |
TERBUTALINE SULFATE INJECTION, USP 1
MG/ML |
BEDFORD LABORATORIES |
4/23/2004 |
| 2 |
76-192 |
RIBAVIRIN CAPSULES 200 MG |
SANDOZ, INC. |
4/6/2004 |
| 3 |
76-203 |
RIBAVIRIN CAPSULES 200 MG |
THREE RIVERS PHARMACEUTICALS, LLC |
4/6/2004 |
| 4 |
75-953 |
TERCONAZOLE VAGINAL CREAM 0.8% |
TARO PHARMACEUTICALS U.S.A., INC. |
4/6/2004 |
| 5 |
76-576 |
SOTALOL HYDROCHLORIDE TABLETS (AF) 80 MG,
120 MG, AND 160 MG |
MUTUAL PHARMACEUTICAL COMPANY, INC. |
4/8/2004 |
| 6 |
76-541 |
MIRTAZAPINE TABLETS 7.5 MG, 15 MG, 30 MG,
AND 45 MG |
CARACO PHARMACEUTICAL LABORATORIES, LTD. |
4/22/2004 |
| 7 |
76-815 |
DIAZEPAM INJECTION, USP 5 MG/ML PACKAGED
IN 5 MG/1 ML AND 10 MG/2 ML SINGLE-DOSE VIALS & 50 MG/ML
MULTIPLE-DOSE VIALS |
PARENTA PHARMACEUTICALS, INC. |
4/15/2004 |
| 8 |
76-483 |
FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG,
AND 40 MG |
EON LABS, INC. |
4/23/2004 |
| 9 |
40-539 |
THEOPHYLLINE EXTENDED-RELEASE TABLETS 600
MG |
ABLE LABORATORIES, INC. |
4/27/2004 |
| 10 |
40-543 |
THEOPHYLLINE EXTENDED-RELEASE TABLETS 400
MG |
ABLE LABORATORIES, INC. |
4/27/2004 |
| 11 |
40-517 |
METHADONE HYDROCHLORIDE TABLETS, USP 5 MG
AND 10 MG |
MALLINCKRODT INC. |
4/27/2004 |
| 12 |
76-294 |
KETOCONAZOLE CREAM 2% |
ALTANA INC. |
4/28/2004 |
| 13 |
76-661 |
FLUDARABINE PHOSPHATE INJECTION 25 MG/ML;
PACKAGED IN 50 MG/2 ML SINGLE-DOSE VIALS |
SICOR PHARMACEUTICALS, INC. |
4/28/2004 |
| 14 |
76-017 |
GABAPENTIN TABLETS 100 MG, 300 MG, AND
400 MG |
IVAX PHARMACEUTICALS, INC. |
4/28/2004 |
| 15 |
76-198 |
NORETHINDRONE AND ETHINYL ESTRADIOL
TABLETS, USP 0.4 MG/0.035 MG; 21-DAY CYCLE (BALZIVA-21
TABLETS) |
BARR LABORATORIES, INC. |
4/22/2004 |
| 16 |
76-238 |
NORETHINDRONE AND ETHINYL ESTRADIOL
TABLETS, USP 0.4 MG/0.035 MG; 28-DAY CYCLE (BALZIVA-28
TABLETS) |
BARR LABORATORIES, INC. |
4/22/2004 |
| 17 |
76-571 |
CLADRIBINE INJECTION 1 MG/ML; PACKAGED IN
10 ML SINGLE-DOSE VIALS |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
4/22/2004 |
| 18 |
76-580 |
FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG,
AND 40 MG |
RANBAXY LABORATORIES LIMITED |
4/23/2004 |
| 19 |
76-550 |
PROPAFENONE HYDROCHLORIDE TABLETS 150 MG,
225 MG, AND 300 MG |
PLIVA, INC. |
4/23/2004 |
| 20 |
76-482 |
METOLAZONE TABLETS, USP 10 MG |
ROXANE LABORATORIES, INC. |
4/29/2004 |
| 21 |
40-546 |
THEOPHYLLINE EXTENDED-RELEASE TABLETS 450
MG |
ABLE LABORATORIES, INC. |
4/30/2004 |
| 22 |
40-548 |
THEOPHYLLINE EXTENDED-RELEASE TABLETS 300
MG |
ABLE LABORATORIES, INC. |
4/30/2004 |
