|
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
1 |
76-395 |
DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES USP, 120 MG, 180 MG, 240 MG, 300 MG, AND 360 MG (ONCE-A-DAY DOSAGE) |
APOTEX INC. |
2/1/2006 |
2 |
76-820 |
BENAZEPRIL HYDROCHLORIDE TABLETS, 5 MG, 10 MG, 20 MG, AND 40 MG |
BIOKEY, INC. |
2/3/2006 |
3 |
77-280 |
GLIMEPIRIDE TABLETS, 1 MG, 2 MG, AND 4 MG |
COBALT PHARMACEUTICALS, INC. |
2/3/2006 |
4 |
77-291 |
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP, 5 MG |
AMIDE PHARMACEUTICAL, INC. |
2/3/2006 |
5 |
40-609 |
HYDROCORTISONE AND ACETIC ACID OTIC SOLUTION USP, 1%/2% |
VINTAGE PHARMACEUTICALS, LLC |
2/6/2006 |
6 |
65-311 |
CEFADROXIL CAPSULES USP, 500 MG |
HIKMA PHARMACEUTICALS |
2/7/2006 |
7 |
76-829 |
AMMONIUM LACTATE CREAM, 12% (AS LACTIC ACID) |
PADDOCK LABORATORIES, INC. |
2/7/2006 |
8 |
77-102 |
CALCITRIOL INJECTION, 0.001 MG/ML (1 MCG/ML); 1 ML VIALS |
GENIX THERAPEUTICS, INC. |
2/8/2006 |
9 |
77-336 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 500 MG AND 750 MG |
SUN PHARMACEUTICAL INDUSTRIES, LTD. |
2/9/2006 |
10 |
77-098 |
OFLOXACIN TABLETS, 200 MG, 300 MG, AND 400 MG |
DR. REDDY'S LABORATORIES LIMITED |
2/10/2006 |
11 |
77-450 |
OCTREOTIDE ACETATE INJECTION, 0.2 MG(BASE)/ML AND 1 MG(BASE)/ML; 5 ML VIALS |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
2/10/2006 |
12 |
77-457 |
OCTREOTIDE ACETATE INJECTION, 0.05 MG(BASE)/ML, 0.1 MG(BASE)/ML, AND 0.5 MG (BASE)/ML; 1 ML VIALS (PRESERVATIVE-FREE) |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
2/10/2006 |
13 |
77-486 |
GLIMEPIRIDE TABLETS, 1 MG, 2 MG, AND 4 MG |
GENPHARM INC. |
2/10/2006 |
14 |
65-312 |
CEFOXITIN FOR INJECTION USP, 10 G/VIAL (PHARMACY BULK PACKAGE) |
ORCHID HEALTHCARE |
2/13/2006 |
15 |
40-649 |
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HBR SYRUP 6.25 MG/15 MG PER 5 ML |
VINTAGE PHARMACEUTICALS, LLC |
2/14/2006 |
16 |
65-254 |
CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION USP, (PLEDGETS) 1% |
ALTANA, INC. |
2/14/2006 |
17 |
76-471 |
LORATADINE TABLETS USP, (OTC) 10 MG |
APOTEX INC. |
2/14/2006 |
18 |
65-245 |
CEFTRIAXONE FOR INJECTION USP, 250 MG/VIAL, 500 MG/VIAL, 1 G/VIAL, AND 2 G/VIAL |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
2/15/2006 |
19 |
65-252 |
CEFTRIAXONE FOR INJECTION USP, 10 GRAMS/VIAL (PHARMACY BULK PACKAGE) |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
2/15/2006 |
20 |
77-266 |
CARBOPLATIN INJECTION, 10 MG/ML; 5 ML, 15 ML, 45 ML, AND 60 ML VIALS |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
2/15/2006 |
21 |
77-404 |
MEGESTROL ACETATE ORAL SUSPENSION USP, 40 MG/ML |
APOTEX INC. |
2/16/2006 |
22 |
77-458 |
RANITIDINE INJECTION USP, 25 MG/ML; 40 ML VIAL (PHARMACY BULK PACKAGE) |
BEDFORD LABORATORIES |
2/16/2006 |
23 |
76-504 |
FLUTICASONE PROPIONATE NASAL SPRAY, 0.05 MG (50 MCG)/ SPRAY |
ROXANE LABORATORIES, INC. |
2/22/2006 |
24 |
77-622 |
LISINOPRIL TABLETS USP, 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MG |
AUROBINDO PHARMA LIMITED |
2/22/2006 |
25 |
75-900 |
FLUVOXAMINE MALEATE TABLETS 25 MG, 50 MG, AND 100 MG |
CARACO PHARMACEUTICAL LABORATORIES, LTD. |
2/23/2006 |
26 |
77-659 |
AMANTADINE HYDROCHLORIDE CAPSULES USP, 100 MG |
AMIDE PHARMACEUTICAL, INC. |
2/23/2006 |
27 |
76-760 |
RANITIDINE TABLETS USP, (OTC) 75 MG |
WOCKHARDT LIMITED |
2/24/2006 |
28 |
65-287 |
DOXYCYCLINE HYCLATE TABLETS USP, 20 MG (BASE) |
PAR PHARMACEUTICAL |
2/28/2006 |