| |
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
| 1 |
40-684 |
EXTENDED PHENYTOIN SODIUM CAPSULES, USP 100 MG |
TARO PHARMACEUTICAL INDUSTRIES, LTD. |
9/5/2006 |
| 2 |
77-101 |
LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP 0.15 MG/0.03 MG |
WATSON LABORATORIES, INC. |
9/6/2006 |
| 3 |
77-500 |
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE TABLETS, (OTC) 2 MG/125 MG |
RANBAXY LABORATORIES LIMITED |
9/6/2006 |
| 4 |
77-721 |
HALOBETASOL PROPIONATE OINTMENT 0.05% |
G & W LABORATORIES, INC. |
9/7/2006 |
| 5 |
76-314 |
TOPIRAMATE TABLETS 25 MG, 100 MG, AND 200 MG |
MYLAN PHARMACEUTICALS, INC. |
9/11/2006 |
| 6 |
65-263 |
CEFTRIAXONE FOR INJECTION USP, 10 GRAMS/VIAL; (PHARMACY BULK PACKAGE) |
LUPIN LIMITED |
9/12/2006 |
| 7 |
76-563 |
DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES USP, (ONCE-A-DAY DOSAGE) 120 MG, 180 MG, 240 MG, 300 MG, 360 MG, AND 420 MG |
K V PHARMACEUTICAL COMPANY |
9/12/2006 |
| 8 |
77-746 |
MIDODRINE HYDROCHLORIDE TABLETS 2.5 MG, 5 MG, AND 10 MG |
APOTEX CORP. |
9/12/2006 |
| 9 |
40-573 |
PHENYTOIN SODIUM INJECTION USP, 50 MG/ML; PACKAGED IN 100 MG/2 ML AND 250 MG/5 ML VIALS |
HIKMA FARMACEUTICA (PORTUGAL), S.A. |
9/13/2006 |
| 10 |
77-443 |
ATENOLOL TABLETS USP, 25 MG, 50 MG, AND 100 MG |
UNIQUE PHARMACEUTICAL LABORATORIES |
9/13/2006 |
| 11 |
77-661 |
GABAPENTIN TABLETS 600 MG AND 800 MG |
APOTEX INC. |
9/13/2006 |
| 12 |
65-297 |
AZITHROMYCIN FOR ORAL SUSPENSION USP, 100 MG/5 ML AND 200 MG/5 ML |
SANDOZ INC. |
9/18/2006 |
| 13 |
65-301 |
CEFADROXIL TABLETS USP, 1 GRAM |
ORCHID HEALTHCARE |
9/18/2006 |
| 14 |
65-309 |
CEFADROXIL CAPSULES USP, 500 MG |
ORCHID HEALTHCARE |
9/18/2006 |
| 15 |
78-010 |
FUROSEMIDE TABLETS USP, 20 MG, 40 MG, AND 80 MG |
OHM LABORATORIES, INC. |
9/18/2006 |
| 16 |
77-287 |
PREDNICARBATE CREAM, 0.1% (EMOLLIENT) 0.1% |
ALTANA INC. |
9/19/2006 |
| 17 |
77-233 |
CAFFEINE CITRATE INJECTION USP, 20 MG/ML; PACKAGED IN 60 MG/3 ML SINGLE-DOSE VIALS |
PHARMAFORCE INC. |
9/21/2006 |
| 18 |
77-304 |
CAFFEINE CITRATE ORAL SOLUTION USP, 20 MG/ML; PACKAGED IN 60 MG/3 ML VIALS |
PHARMAFORCE INC. |
9/21/2006 |
| 19 |
40-637 |
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BIRARTRATE TABLE 712.8 MG/60 MG/32 MG |
WEST-WARD PHARMACEUTICAL CORP. |
9/22/2006 |
| 20 |
77-351 |
FAMOTIDINE TABLETS USP, (OTC) 20 MG |
PERRIGO R&D COMPANY |
9/25/2006 |
| 21 |
77-367 |
FAMOTIDINE TABLETS USP, (OTC) 20 MG |
DR REDDY'S LABORATORIES LIMITED |
9/25/2006 |
| 22 |
75-503 |
BALANCED SALT SOLUTION (STERILE IRRIGATION SOLUTION) |
AKORN, INC. |
9/27/2006 |
| 23 |
77-250 |
BUPIVACAINE HCL & EPINEPHRINE INJECTION USP, 0.5%/1:200,000; PACKAGED IN 1.8 ML CARTRIDGES |
SEPTODONT INC. |
9/27/2006 |
| 24 |
77-381 |
NAPROXEN SODIUM & PSEUROEPHEDRINE HCL EXTENDED-RELEASE TABLE 220 MG/120 MG; (OTC) |
DR. REDDY'S LABORATORIES LIMITED |
9/27/2006 |
| 25 |
77-706 |
POLYETHYLENE GLYCOL 3350 NF, POWDER FOR ORAL SOLUTION 17 GRAMS/SCOOPFUL |
YVR THERAPEUTICS, LLC |
9/27/2006 |
| 26 |
77-912 |
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG |
LUPIN LIMITED |
9/27/2006 |
| 27 |
40-680 |
OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN ORAL SOLUTION 5 MG/325 MG PER 5 ML |
TYCO HEALTHCARE MALLINCKRODT |
9/29/2006 |
| 28 |
77-432 |
CARBOPLATIN INJECTION 10 MG/ML; PACKAGED IN 50 MG/5 ML, 150 MG/15 ML, AND 450 MG/45 ML MULTIPLE-DOSE VIALS |
DABUR ONCOLOGY PLC |
9/29/2006 |
| 29 |
77-891 |
ZONISAMIDE CAPSULES 25 MG AND 50 MG |
DR. REDDY'S LABORATORIES LIMITED |
9/29/2006 |
