|
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
1 |
40-558 |
PROMETHAZINE HYDROCHLORIDE TABLETS, USP
12.5 MG, 25 MG, AND 50 MG |
ABLE LABORATORIES, INC. |
7/1/2004 |
2 |
76-652 |
GLYCOLAX (POLYETHYLENE GLYCOL 3350 POWDER
FOR ORAL SOLUTION) |
SCHWARZ PHARMA, INC. |
7/2/2004 |
3 |
65-157 |
PIPERACILLIN FOR INJECTION, USP 40 G/VIAL
(PHARMACY BULK PACKAGE) |
ISTITUTO BIOCHIMICO ITALIANO, S.P.A. |
7/12/2004 |
4 |
65-203 |
NYSTATIN TOPICAL POWDER, USP 100,000
UNITS/GRAM |
TANON PHARMACEUTICALS LLC |
7/15/2004 |
5 |
76-020 |
MIDAZOLAM HYDROCHLORIDE INJECTION 1 MG
(BASE)/ML AND 5 MG (BASE)/ML |
INTERNATIONAL MEDICATION SYSTEMS, LIMITE |
7/16/2004 |
6 |
76-853 |
TERBUTALINE SULFATE INJECTION, USP 1
MG/ML; PACKAGED IN 1 ML SINGLE-DOSE VIALS |
SICOR PHARMACEUTICALS, INC. |
7/20/2004 |
7 |
75-772 |
KETOROLAC TROMETHAMINE INJECTION, USP 15
MG/ML, 30 MG/ML, AND 60 MG/2 ML; SINGLE-DOSE VIALS. |
BAXTER HEALTHCARE CORPORATION |
7/21/2004 |
8 |
76-209 |
KETOROLAC TROMETHAMINE INJECTION, USP 15
MG/ML, 30 MG/ML, AND 60 MG/2 ML, PACKAGED IN SINGLE-DOSE
VIALS |
AMPHASTAR PHARMACEUTICALS, INC. |
7/21/2004 |
9 |
76-891 |
METOLAZONE TABLETS, USP 10 MG |
WATSON LABORATORIES, INC. |
7/21/2004 |
10 |
40-559 |
HYDROXYZINE HYDROCHLORIDE TABLETS, USP 10
MG |
ABLE LABORATORIES, INC. |
7/22/2004 |
11 |
40-562 |
HYDROXYZINE HYDROCHLORIDE TABLETS, USP 25
MG |
ABLE LABORATORIES, INC. |
7/22/2004 |
12 |
40-563 |
HYDROXYZINE HYDROCHLORIDE TABLETS, USP 50
MG |
ABLE LABORATORIES, INC. |
7/22/2004 |
13 |
65-138 |
NYSTATIN TOPICAL POWDER, USP 100,000
UNITS/GRAM |
KALI LABORATORIES, INC. |
7/23/2004 |
14 |
76-883 |
SOTALOL HYDROCHLORIDE TABLETS, USP (AF)
80 MG, 120 MG, AND 160 MG |
TEVA PHARMACEUTICALS USA |
7/26/2004 |
15 |
40-483 |
BETHANECHOL CHLORIDE TABLETS, USP 10 MG |
ABLE LABORATORIES, INC. |
7/27/2004 |
16 |
40-485 |
BETHANECHOL CHLORIDE TABLETS, USP 25 MG |
ABLE LABORATORIES, INC. |
7/27/2004 |
17 |
40-492 |
BETHANECHOL CHLORIDE TABLETS, USP 5 MG |
ABLE LABORATORIES, INC. |
7/27/2004 |
18 |
40-509 |
BETHANECHOL CHLORIDE TABLETS, USP 50 MG |
ABLE LABORATORIES, INC. |
7/27/2004 |
19 |
76-722 |
KETOROLAC TROMETHAMINE INJECTION, USP 15
MG/1 ML, 30 MG/1 ML AND 60 MG/2 ML; PACKAGED IN
SINGLE-DOSE SYRINGES |
APOTEX CORP. |
7/27/2004 |
20 |
76-493 |
CLOTRIMAZOLE AND BETAMETHASONE
DIPROPIONATE LOTION 1%/0.05% (BASE) |
TARO PHARMACEUTICALS U.S.A., INC. |
7/28/2004 |
21 |
76-553 |
MEDROXYPROGESTERONE ACETATE INJECTABLE
SUSPENSION, USP 150 MG/1 ML SINGLE-DOSE VIALS |
SICOR PHARMACEUTICALS, INC. |
7/28/2004 |
22 |
74-681 |
FLUCONAZOLE TABLETS 50 MG, 100 MG, 150
MG, AND 200 MG |
NOVOPHARM LIMITED |
7/29/2004 |
23 |
76-042 |
FLUCONAZOLE TABLETS 50 MG, 100 MG, 150
MG, AND 200 MG |
GENPHARM INC. |
7/29/2004 |
24 |
76-077 |
FLUCONAZOLE TABLETS 50 MG, 100 MG, 150
MG, AND 200 MG |
IVAX PHARMACEUTICALS, INC. |
7/29/2004 |
25 |
76-086 |
FLUCONAZOLE TABLETS 50 MG, 100 MG, 150
MG, AND 200 MG |
SANDOZ INC. |
7/29/2004 |
26 |
76-087 |
FLUCONAZOLE INJECTION (IN 0.9% SODIUM
CHLORIDE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND
400 MG/200 ML SINGLE-DOSE VIALS. |
BEDFORD LABORATORIES |
7/29/2004 |
27 |
76-145 |
FLUCONAZOLE INJECTION (IN 0.9% SODIUM
CHLORIDE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND
400 MG/200 ML SINGLE-DOSE VIALS |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
7/29/2004 |
28 |
76-213 |
FLUCONAZOLE TABLETS 50 MG, 100 MG, 150
MG, AND 200 MG |
ROXANE LABORATORIES, INC. |
7/29/2004 |
29 |
76-246 |
FLUCONAZOLE FOR ORAL SUSPENSION 10 MG/ML
(50 MG/5 ML) AND 40 MG/ML (200 MG/5 ML) |
ROXANE LABORATORIES, INC. |
7/29/2004 |
30 |
76-303 |
FLUCONAZOLE INJECTION (IN 0.9% SODIUM
CHLORIDE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND
400 MG/200 ML SINGLE-DOSE PLASTIC CONTAINERS. |
HOSPIRA, INC. |
7/29/2004 |
31 |
76-304 |
FLUCONAZOLE INJECTION (IN 5% DEXTROSE
INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND 400
MG/200 ML SINGLE-DOSE PLASTIC CONTAINERS |
HOSPIRA, INC. |
7/29/2004 |
32 |
76-332 |
FLUCONAZOLE FOR ORAL SUSPENSION 10 MG/ML
(50 MG/5 ML) AND 40 MG/ML (200 MG/5 ML) |
RANBAXY LABORATORIES LIMITED |
7/29/2004 |
33 |
76-351 |
FLUCONAZOLE TABLETS 50 MG, 100 MG, 150
MG, AND 200 MG |
MYLAN PHARMACEUTICALS, INC. |
7/29/2004 |
34 |
76-386 |
FLUCONAZOLE TABLETS 50 MG, 100 MG, 150
MG, 200 MG |
RANBAXY LABORATORIES LIMITED |
7/29/2004 |
35 |
76-387 |
CLOTRIMAZOLE LOZENGES, USP 10 MG |
ROXANE LABORATORIES, INC. |
7/29/2004 |
36 |
76-424 |
FLUCONAZOLE TABLETS 50 MG, 100 MG, 150
MG, AND 200 MG |
PLIVA INC. |
7/29/2004 |
37 |
76-432 |
FLUCONAZOLE TABLETS 50 MG, 100 MG, 150
MG, AND 200 MG |
GEDEON RICHTER LTD. |
7/29/2004 |
38 |
76-507 |
FLUCONAZOLE TABLETS 50 MG, 100 MG, 150
MG, AND 200 MG |
TARO PHARMACEUTICAL INDUSTRIES, LTD. |
7/29/2004 |
39 |
76-568 |
NICOTINE POLACRILEX GUM, USP
(MINT-FLAVORED) (OTC) 4 MG (BASE) |
WATSON LABORATORIES, INC. |
7/29/2004 |
40 |
76-569 |
NICOTINE POLACRILEX GUM, USP (MINT
FLAVORED) (OTC) 2 MG (BASE) |
WATSON LABORATORIES, INC. |
7/29/2004 |
41 |
76-617 |
FLUCONAZOLE INJECTION (IN 0.9% SODIUM
CHLORIDE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND
400 MG/200 ML SINGLE-DOSE PLASTIC CONTAINERS |
MAYNE PHARMA (USA) INC. |
7/29/2004 |
42 |
76-653 |
FLUCONAZOLE INJECTION (IN 0.9% SODIUM
CHLORIDE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML,
AND 400 MG/200 ML SINGLE-DOSE VIALS |
SICOR PHARMACEUTICALS, INC. |
7/29/2004 |
43 |
76-658 |
FLUCONAZOLE TABLETS 50 MG, 100 MG, 150
MG, AND 200 MG |
DR. REDDY'S LABORATORIES LIMITED |
7/29/2004 |
44 |
76-665 |
FLUCONAZOLE TABLETS 50 MG, 100 MG, 150
MG, AND 200 MG |
APOTEX INC. |
7/29/2004 |
45 |
76-730 |
ALCLOMETASONE DIPROPIONATE OINTMENT, USP
0.05% |
TARO PHARMACEUTICALS USA, INC. |
7/29/2004 |
46 |
76-766 |
FLUCONAZOLE INJECTION (IN 0.9% SODIUM
CHLORIDE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND
400 MG/200 ML SINGLE-DOSE PLASTIC CONTAINERS |
BAXTER HEALTHCARE CORPORATION |
7/29/2004 |
47 |
40-583 |
METHYLPREDNISOLONE SODIUM SUCCINATE FOR
INJECTION, USP 40 MG (BASE)/VIAL AND 125 MG (BASE)/VIAL |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
7/30/2004 |
48 |
65-024 |
GENTAMICIN OPHTHALMIC OINTMENT, USP 0.3%
|
ALTANA INC. |
7/30/2004 |
49 |
76-249 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE
TABLETS 500 MG |
IMPAX LABORATORIES, INC. |
7/30/2004 |
50 |
76-907 |
ATENOLOL TABLETS, USP 25 MG, 50 MG, AND
100 MG |
ABLE LABORATORIES, INC. |
7/30/2004 |