|
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
1 |
76-379 |
MIDAZOLAM HYDROCHLORIDE SYRUP, 2 MG
(BASE)/ML |
PADDOCK LABORATORIES, INC. |
5/2/2005 |
2 |
76-474 |
ESMOLOL HYDROCHLORIDE INJECTION 10 MG/ML;
10 ML VIALS |
PHARMAFORCE, INC. |
5/2/2005 |
3 |
76-573 |
ESMOLOL HYDROCHLORIDE INJECTION 10 MG/ML;
10 ML VIALS |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
5/2/2005 |
4 |
77-147 |
CLONAZEPAM TABLETS USP 0.5 MG, 1 MG, AND
2 MG |
KALI LABORATORIES, INC. |
5/2/2005 |
5 |
65-183 |
NYSTATIN TOPICAL POWDER USP, 100,000
UNITS/GRAM |
UPSHER-SMITH LABORATORIES, INC. |
5/3/2005 |
6 |
65-204 |
CEFTRIAXONE FOR INJECTION USP, 1 G AND 2
G VIALS |
SANDOZ, INC. |
5/3/2005 |
7 |
77-071 |
FLUMAZENIL INJECTION USP, 0.1 MG/ML; 5 ML
AND 10 ML VIALS |
SABEX 2002 INC. |
5/3/2005 |
8 |
65-169 |
CEFTRIAXONE FOR INJECTION USP, 250 MG,
500 MG, 1 G, AND 2 G VIALS |
SANDOZ, INC. |
5/9/2005 |
9 |
76-291 |
IPRATROPIUM BROMIDE INHALATION SOLUTION,
0.02%; 0.5 MG/2.5 ML VIALS |
BREATH LIMITED |
5/9/2005 |
10 |
65-103 |
DOXYCYCLINE HYCLATE CAPSULES USP, 20 MG |
WEST-WARD PHARMACEUTICAL CORP. |
5/13/2005 |
11 |
65-134 |
DOXYCYCLINE HYCLATE TABLETS USP, 20 MG |
MUTUAL PHARMACEUTICAL COMPANY, INC. |
5/13/2005 |
12 |
65-163 |
DOXYCYCLINE HYCLATE TABLETS USP, 20 MG |
IVAX PHARMACEUTICALS, INC. |
5/13/2005 |
13 |
65-182 |
DOXYCYCLINE HYCLATE TABLETS USP, 20 MG |
COREPHARMA LLC |
5/13/2005 |
14 |
76-433 |
FENOFIBRATE TABLETS, 54 MG AND 160 MG |
TEVA PHARMACEUTICALS USA |
5/13/2005 |
15 |
65-168 |
CEFTRIAXONE FOR INJECTION USP, 10 G/VIAL
(PHARMACY BULK PACKAGE) |
SANDOZ, INC. |
5/17/2005 |
16 |
76-906 |
FOSINOPRIL SODIUM TABLETS, 10 MG, 20 MG,
AND 40 MG |
APOTEX INC. |
5/17/2005 |
17 |
77-024 |
CILOSTAZOL TABLETS, 50 MG AND 100 MG |
ROXANE LABORATORIES, INC. |
5/17/2005 |
18 |
65-154 |
CLARITHROMYCIN EXTENDED-RELEASE TABLETS,
500 MG |
TEVA PHARMACEUTICALS USA |
5/18/2005 |
19 |
76-251 |
FLUOXETINE CAPSULES USP, 40 MG |
BARR LABORATORIES, INC. |
5/18/2005 |
20 |
77-077 |
NORETHINDRONE ACETATE AND ETHINYL
ESTRADIOL TABLETS USP, AND FERROUS FUMARATE TABLETS, 1
MG/0.02 MG/75 MG |
ANDRX PHARMACEUTICALS, LLC |
5/20/2005 |
21 |
76-785 |
ETHYNODIOL DIACETATE AND ETHINYL
ESTRADIOL TABLETS USP, 1 MG/35 MCG; PACKAGED IN 28-DAY
REGIMENS |
BARR LABORATORIES, INC. |
5/23/2005 |
22 |
76-982 |
PREDNISOLONE SODIUM PHOSPHATE ORAL
SOLUTION, 5 MG (BASE)/5 ML |
KV PHARMACEUTICAL COMPANY |
5/24/2005 |
23 |
76-988 |
PREDNISOLONE SODIUM PHOSPHATE ORAL
SOLUTION, 15 MG (BASE)/5 ML |
KV PHARMACEUTICAL COMPANY |
5/24/2005 |
24 |
40-574 |
HYDROXYZINE HYDROCHLORIDE TABLETS USP, 25
MG |
VINTAGE PHARMACEUTICALS, LLC |
5/27/2005 |
25 |
40-579 |
HYDROXYZINE HYDROCHLORIDE TABLETS USP, 10
MG |
VINTAGE PHARMACEUTICALS, LLC |
5/27/2005 |
26 |
40-580 |
HYDROXYZINE HYDROCHLORIDE TABLETS USP, 50
MG |
VINTAGE PHARMACEUTICALS, LLC |
5/27/2005 |
27 |
65-137 |
CLARITHROMYCIN TABLETS USP, 250 MG AND
500 MG |
IVAX PHARMACEUTICALS, INC. |
5/31/2005 |
28 |
65-155 |
CLARITHROMYCIN TABLETS USP, 250 MG AND
500 MG |
TEVA PHARMACEUTICALS USA |
5/31/2005 |
29 |
76-894 |
TORSEMIDE TABLETS, 5 MG, 10 MG, 20 MG,
AND 100 MG |
APOTEX INC. |
5/31/2005 |
30 |
77-174 |
FOSCARNET SODIUM INJECTION, 24 MG/ML; 250
ML AND 500 ML BOTTLES |
PHARMAFORCE, INC. |
5/31/2005 |