| |
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
| 1 |
65-230 |
CEFTRIAXONE FOR INJECTION USP, 250
MG/VIAL, 500 MG/VIAL, 1 G/VIAL, AND 2 G/VIAL |
ORCHID HEALTHCARE |
8/2/2005 |
| 2 |
65-231 |
CEFTRIAXONE FOR INJECTION USP, 1 G/VIAL
AND 2 G/VIAL |
ORCHID HEALTHCARE |
8/2/2005 |
| 3 |
65-232 |
CEFTRIAXONE FOR INJECTION USP, 10 G/VIAL
PHARMACY BULK PACKAGE |
ORCHID HEALTHCARE |
8/2/2005 |
| 4 |
76-654 |
HYDROCORTISONE BUTYRATE CREAM USP, 0.1% |
TARO PHARMACEUTICAL INDUSTRIES LTD. |
8/3/2005 |
| 5 |
77-171 |
CLONAZEPAM ORALLY DISINTEGRATING TABLETS,
0.125 MG, 0.25 MG, 0.5 MG, 1 MG, AND 2 MG |
KALI LABORATORIES, INC. |
8/3/2005 |
| 6 |
76-868 |
LOXAPINE CAPSULES USP, 5 MG (BASE), 10 MG
(BASE), 25 MG (BASE), AND 50 MG (BASE) |
AMIDE PHARMACEUTICAL, INC. |
8/4/2005 |
| 7 |
77-227 |
HALOBETASOL PROPRIONATE CREAM, 0.05% |
TARO PHARMACEUTICALS USA, INC. |
8/4/2005 |
| 8 |
76-977 |
CLOBETASOL PROPIONATE TOPICAL SOLUTION
USP, 0.05% |
QLT USA, INC. |
8/5/2005 |
| 9 |
77-092 |
CICLOPIROX TOPICAL SUSPENSION USP
(LOTION), 0.77% |
TARO PHARMACEUTICALS USA, INC. |
8/10/2005 |
| 10 |
77-194 |
CLONAZEPAM ORALLY DISINTEGRATING TABLETS,
0.125 MG, 0.25 MG, 0.5 MG, 1 MG, AND 2 MG |
BARR LABORATORIES, INC. |
8/10/2005 |
| 11 |
40-632 |
METHOTREXATE FOR INJECTION USP
(PRESERVATIVE-FREE), 1 GRAM/VIAL |
BEDFORD LABORATORIES |
8/12/2005 |
| 12 |
65-242 |
CLINDAMYCIN HYDROCHLORIDE CAPSULES USP,
75 MG (BASE) AND 150 MG (BASE) |
LANNETT HOLDINGS, INC. |
8/12/2005 |
| 13 |
65-243 |
CLINDAMYCIN HYDROCHLORIDE CAPSULES USP,
300 MG (BASE) |
LANNETT HOLDINGS, INC. |
8/12/2005 |
| 14 |
65-244 |
CEFAZOLIN FOR INJECTION USP, 1 G/VIAL |
ORCHID HEALTHCARE |
8/12/2005 |
| 15 |
65-247 |
CEFAZOLIN FOR INJECTION, 10 GRAM/VIAL
(PHARMACY BULK PACKAGE) |
ORCHID HEALTHCARE |
8/12/2005 |
| 16 |
76-618 |
PAROXETINE TABLETS USP, 10 MG , 20 MG ,
30 MG, AND 40 MG |
TEVA PHARMACEUTICALS USA |
8/15/2005 |
| 17 |
77-144 |
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
TABLETS, 10 MG/12.5 MG AND 20 MG/12.5 MG |
WATSON LABORATORIES, INC. |
8/16/2005 |
| 18 |
65-234 |
CEPHALEXIN FOR ORAL SUSPENSION USP, 125
MG/5 ML AND 250 MG/5 ML |
LUPIN LIMITED |
8/17/2005 |
| 19 |
76-923 |
LIOTHYRONINE SODIUM INJECTION, 10
MCG(BASE)/ML; 1 ML VIALS |
PHARMAFORCE, INC. |
8/17/2005 |
| 20 |
77-040 |
CITALOPRAM HYDROBROMIDE TABLETS, 10 MG
(BASE), 20 MG (BASE), AND 40 MG (BASE) |
SANDOZ INC. |
8/17/2005 |
| 21 |
40-610 |
PHENYTOIN ORAL SUSPENSION USP, 125 MG/5
ML |
VISTAPHARM, INC. |
8/18/2005 |
| 22 |
65-189 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
TABLETS USP, 250 MG/125 MG (BASE) |
SANDOZ INC. |
8/23/2005 |
| 23 |
65-224 |
CEFTRIAXONE INJECTION USP, 1 GRAM/50 ML
AND 2 GRAMS/50 ML, PACKAGED IN GALAXY SINGLE-DOSE PLASTIC
CONTAINERS |
BAXTER HEALTHCARE CORPORATION |
8/23/2005 |
| 24 |
76-736 |
FLUCONAZOLE INJECTION (IN 0.9% SODIUM
CHLORIDE), 2 MG/ML; 100 ML VIALS |
HIKMA FARMACEUTICA (PORTUGAL), LDA |
8/23/2005 |
| 25 |
40-570 |
PREDNISOLONE SYRUP USP, 5 MG/5 ML |
APOTEX INC. |
8/25/2005 |
| 26 |
40-571 |
PREDNISOLONE SYRUP USP, 15 MG/5 ML |
APOTEX INC. |
8/25/2005 |
| 27 |
65-136 |
CLARITHROMYCIN TABLETS USP, 500 MG |
SANDOZ INC. |
8/25/2005 |
| 28 |
65-250 |
CLARITHROMYCIN EXTENDED-RELEASE TABLETS,
500 MG |
SANDOZ INC. |
8/25/2005 |
| 29 |
77-203 |
CHOLESTYRAMINE FOR ORAL SUSPENSION USP,
(LIGHT) 4 GRAMS OF RESIN/SCOOPFUL OR PACKET |
PAR PHARMACEUTICAL, INC. |
8/26/2005 |
| 30 |
77-204 |
CHOLESTYRAMINE FOR ORAL SUSPENSION USP, 4
G RESIN/ 9 G SCOOPFUL OR PACKET |
PAR PHARMACEUTICAL, INC. |
8/26/2005 |
| 31 |
77-068 |
BACLOFEN TABLETS USP, 20 MG |
VINTAGE PHARMACEUTICALS, LLC |
8/30/2005 |
| 32 |
77-156 |
BACLOFEN TABLETS USP, 10 MG |
VINTAGE PHARMACEUTICALS, LLC |
8/30/2005 |
| 33 |
76-191 |
FEXOFENADINE HYDROCHLORIDE TABLETS, 30
MG, 60 MG, AND 180 MG |
BARR LABORATORIES, INC. |
8/31/2005 |
| 34 |
76-689 |
MIRTAZAPINE ORALLY DISINTEGRATING
TABLETS, 15 MG, 30 MG, AND 45 MG |
AMIDE PHARMACEUTICAL, INC. |
8/31/2005 |
