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U.S. Department of Health and Human Services

Drugs

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Approvals - September 2006

 ANDA NumberGeneric Drug NameApplicantApproval Date
140-684EXTENDED PHENYTOIN SODIUM CAPSULES, USP 100 MGTARO PHARMACEUTICAL INDUSTRIES, LTD.9/5/2006
277-101LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP 0.15 MG/0.03 MGWATSON LABORATORIES, INC.9/6/2006
377-500LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE TABLETS, (OTC) 2 MG/125 MGRANBAXY LABORATORIES LIMITED9/6/2006
477-721HALOBETASOL PROPIONATE OINTMENT 0.05%G & W LABORATORIES, INC.9/7/2006
576-314TOPIRAMATE TABLETS 25 MG, 100 MG, AND 200 MGMYLAN PHARMACEUTICALS, INC.9/11/2006
665-263CEFTRIAXONE FOR INJECTION USP, 10 GRAMS/VIAL; (PHARMACY BULK PACKAGE)LUPIN LIMITED9/12/2006
776-563DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES USP, (ONCE-A-DAY DOSAGE) 120 MG, 180 MG, 240 MG, 300 MG, 360 MG, AND 420 MGK V PHARMACEUTICAL COMPANY9/12/2006
877-746MIDODRINE HYDROCHLORIDE TABLETS 2.5 MG, 5 MG, AND 10 MGAPOTEX CORP.9/12/2006
940-573PHENYTOIN SODIUM INJECTION USP, 50 MG/ML; PACKAGED IN 100 MG/2 ML AND 250 MG/5 ML VIALSHIKMA FARMACEUTICA (PORTUGAL), S.A.9/13/2006
1077-443ATENOLOL TABLETS USP, 25 MG, 50 MG, AND 100 MGUNIQUE PHARMACEUTICAL LABORATORIES9/13/2006
1177-661GABAPENTIN TABLETS 600 MG AND 800 MGAPOTEX INC.9/13/2006
1265-297AZITHROMYCIN FOR ORAL SUSPENSION USP, 100 MG/5 ML AND 200 MG/5 MLSANDOZ INC.9/18/2006
1365-301CEFADROXIL TABLETS USP, 1 GRAMORCHID HEALTHCARE9/18/2006
1465-309CEFADROXIL CAPSULES USP, 500 MGORCHID HEALTHCARE9/18/2006
1578-010FUROSEMIDE TABLETS USP, 20 MG, 40 MG, AND 80 MGOHM LABORATORIES, INC.9/18/2006
1677-287PREDNICARBATE CREAM, 0.1% (EMOLLIENT) 0.1%ALTANA INC.9/19/2006
1777-233CAFFEINE CITRATE INJECTION USP, 20 MG/ML; PACKAGED IN 60 MG/3 ML SINGLE-DOSE VIALSPHARMAFORCE INC.9/21/2006
1877-304CAFFEINE CITRATE ORAL SOLUTION USP, 20 MG/ML; PACKAGED IN 60 MG/3 ML VIALSPHARMAFORCE INC.9/21/2006
1940-637ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BIRARTRATE TABLE 712.8 MG/60 MG/32 MGWEST-WARD PHARMACEUTICAL CORP.9/22/2006
2077-351FAMOTIDINE TABLETS USP, (OTC) 20 MGPERRIGO R&D COMPANY9/25/2006
2177-367FAMOTIDINE TABLETS USP, (OTC) 20 MGDR REDDY'S LABORATORIES LIMITED9/25/2006
2275-503BALANCED SALT SOLUTION (STERILE IRRIGATION SOLUTION)AKORN, INC.9/27/2006
2377-250BUPIVACAINE HCL & EPINEPHRINE INJECTION USP, 0.5%/1:200,000; PACKAGED IN 1.8 ML CARTRIDGESSEPTODONT INC.9/27/2006
2477-381NAPROXEN SODIUM & PSEUROEPHEDRINE HCL EXTENDED-RELEASE TABLE 220 MG/120 MG; (OTC)DR. REDDY'S LABORATORIES LIMITED9/27/2006
2577-706POLYETHYLENE GLYCOL 3350 NF, POWDER FOR ORAL SOLUTION 17 GRAMS/SCOOPFULYVR THERAPEUTICS, LLC9/27/2006
2677-912LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MGLUPIN LIMITED9/27/2006
2740-680OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN ORAL SOLUTION 5 MG/325 MG PER 5 MLTYCO HEALTHCARE MALLINCKRODT9/29/2006
2877-432CARBOPLATIN INJECTION 10 MG/ML; PACKAGED IN 50 MG/5 ML, 150 MG/15 ML, AND 450 MG/45 ML MULTIPLE-DOSE VIALSDABUR ONCOLOGY PLC9/29/2006
2977-891ZONISAMIDE CAPSULES 25 MG AND 50 MGDR. REDDY'S LABORATORIES LIMITED9/29/2006