|
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
1 |
76-513 |
OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% |
NOVEX PHARMA |
5/14/2004 |
2 |
75-988 |
PREDNISOLONE SODIUM PHOSPHATE ORAL
SOLUTION 5 MG (BASE)/ 5 ML |
PADDOCK LABORATORIES, INC. |
5/25/2004 |
3 |
65-178 |
CLARITHROMYCIN TABLETS, USP 250 MG AND
500 MG |
ROXANE LABORATORIES, INC. |
5/25/2004 |
4 |
76-887 |
TERBUTALINE SULFATE INJECTION, USP 1
MG/ML, PACKAGED IN 1 ML SINGLE-DOSE VIALS. |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
5/26/2004 |
5 |
75-914 |
BUPROPION HYDROCHLORIDE EXTENDED-RELEASE
TABLETS 150 MG (RLD = ZYBAN/GSK) |
IMPAX LABORATORIES, INC. |
5/27/2004 |
6 |
76-449 |
MIDODRINE HYDROCHLORIDE TABLETS 2.5 MG
AND 5 MG |
IMPAX LABORATORIES, INC. |
5/27/2004 |
7 |
76-408 |
METRONIDAZOLE TOPICAL CREAM 0.75% |
ALTANA INC. |
5/28/2004 |
8 |
40-540 |
PROCHLORPERAZINE EDISYLATE INJECTION, USP
5 MG (BASE)/ML; PACKAGED IN 10 MG (BASE)/2 ML SINGLE-DOSE
VIALS AND 50 MG (BASE)/10 ML MULTIPLE-DOSE VIALS |
BEDFORD LABORATORIES |
5/28/2004 |
9 |
76-231 |
OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% |
ALCON INC. |
5/14/2004 |
10 |
76-622 |
OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% |
BAUSCH & LOMB, INC. |
5/14/2004 |
11 |
76-300 |
FLUTICASONE PROPIONATE OINTMENT 0.005% |
ALTANA INC. |
5/14/2004 |
12 |
76-743 |
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
TABLETS, USP 100 MG/325 MG |
VINTAGE PHARMACEUTICALS, INC. |
5/7/2004 |
13 |
76-633 |
FLUTICASONE PROPIONATE CREAM 0.05% |
ATRIX LABORATORIES, INC, |
5/14/2004 |
14 |
76-668 |
FLUTICASONE PROPIONATE OINTMENT 0.005% |
CLAY-PARK LABS, INC. |
5/14/2004 |
15 |
76-793 |
FLUTICASONE PROPIONATE CREAM 0.05% |
CLAY-PARK LABS, INC. |
5/14/2004 |
16 |
76-451 |
FLUTICASONE PROPIONATE CREAM 0.05% |
ALTANA INC. |
5/14/2004 |
17 |
76-615 |
OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% |
HI-TECH PHARMACAL CO., INC. |
5/14/2004 |
18 |
76-458 |
FLUOXETINE ORAL SOLUTION, USP 20 MG
(BASE)/5 ML |
PAR PHARMACEUTICAL, INC. |
5/14/2004 |
19 |
76-521 |
CARBIDOPA-LEVODOPA EXTENDED-RELEASE
TABLETS 25 MG/100 MG, AND 50 MG/200 MG |
IMPAX LABORATORIES, INC. |
5/14/2004 |
20 |
76-733 |
MORPHINE SULFATE EXTENDED-RELEASE TABLETS
15 MG |
KV PHARMACEUTICAL COMPANY |
5/19/2004 |
21 |
76-720 |
MORPHINE SULFATE EXTENDED-RELEASE TABLETS
60 MG |
KV PHARMACEUTICAL COMPANY |
5/19/2004 |
22 |
76-151 |
DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE
CAPSULES, USP 120 MG, 180 MG, 240 MG, AND 300 MG
(ONCE-A-DAY DOSAGE) |
TORPHARM INC. |
5/20/2004 |
23 |
65-089 |
AMOXICILLIN & CLAVULANATE POTASSIUM FOR
ORAL SUSPENSION, USP 200 MG/28.5 MG (BASE)/5 ML AND 400
MG/57 MG (BASE)/5 ML |
TEVA PHARMACEUTICALS USA |
5/25/2004 |
24 |
76-104 |
ITRACONAZOLE CAPSULES 100 MG |
EON LABS, INC. |
5/28/2004 |
25 |
76-216 |
AMMONIUM LACTATE LOTION 12% (BASE) |
TARO PHARMACEUTICALS USA, INC. |
5/28/2004 |