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U.S. Department of Health and Human Services

Drugs

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Approvals - May 2006

  ANDA Number Generic Drug Name Applicant Approval Date
1 65-219 NEOMYCIN & POLYMYXIN B SULFATES & HYDROCORTISONE OTIC SUSPENSION, 3.5 MG (BASE)/10,000 U,1%/ML PHARMAFORCE, INC. 5/1/2006 
2 65-274 CEFTRIAXONE FOR INJECTION USP, 10 G/VIAL (PHARMACY BULK PACKAGE) TEVA PHARMACEUTICALS USA 5/1/2006 
3 77-277 COLESTIPOL HYDROCHLORIDE FOR ORAL SUSPENSION USP, 5 G PACKET OR SCOOPFUL IMPAX LABORATORIES, INC. 5/2/2006 
4 77-445 POLYETHYLENE GLYCOL 3350 NF POWDER FOR ORAL SOLUTION, 17 G PACKET OR SCOOPFUL TEVA PHARMACEUTICALS USA 5/4/2006 
5 77-354 KETOTIFEN FUMARATE OPHTHALMIC SOLUTION, 0.025% APOTEX, INC. 5/9/2006 
6 77-754 LORAZEPAM TABLETS USP, 0.5 MG, 1 MG, AND 2 MG VINTAGE PHARMACEUTICALS, LLC 5/10/2006 
7 65-180 CEFTRIAXONE FOR INJECTION USP, 1 GRAM/VIAL WOCKHARDT LIMITED 5/12/2006 
8 40-679 OXYCODONE AND ACETAMINOPHEN TABLETS USP, 2.5 MG/400 MG MIKART INC. 5/16/2006 
9 65-264 CEFDINIR CAPSULES, 300 MG LUPIN LIMITED 5/19/2006 
10 76-765 ESCITALOPRAM OXALATE TABLETS, 5 MG, 10 MG, AND 20 MG IVAX PHARMACEUTICALS, INC. 5/22/2006 
11 77-447 MOMETASONE FUROATE CREAM USP, 0.1% G&W LABORATORIES, INC. 5/22/2006 
12 40-484 ORPHENADRINE CITRATE INJECTION USP, 30 MG/ML; 2 ML VIALS AKORN INC. 5/24/2006 
13 77-197 METRONIDAZOLE TOPICAL LOTION, 0.75% ALTANA INC. 5/24/2006 
14 77-893 POLYETHYLENE GLYCOL 3350 NF POWDER FOR ORAL SOLUTION, 17 GRAMS/SCOOPFUL COASTAL PHARMACEUTICALS, INC. 5/24/2006 
15 77-736 POLYETHYLENE GLYCOL 3350 NF POWDER FOR ORAL SOLUTION, 17 GRAMS/SCOOPFUL KALI LABORATORIES, INC. 5/26/2006 
16 40-644 CYPROHEPTADINE HYDROCHLORIDE TABLETS USP, 4 MG STASON PHARMACEUTICALS, INC. 5/30/2006 
17 40-663 WARFARIN SODIUM TABLETS USP, 1 MG, 2 MG, 2.5 MG, 3 MG, 4 MG, 5 MG, 6 MG, 7.5 MG, AND 10 MG ZYDUS PHARMACEUTICALS USA, INC. 5/30/2006 
18 65-259 CEFDINIR FOR ORAL SUSPENSION, 125 MG/5 ML LUPIN PHARMACEUTICALS INC. 5/31/2006 
19 65-266 CLARITHROMYCIN TABLETS USP, 250 MG AND 500 MG WOCKHARDT LIMITED 5/31/2006 
20 65-315 NYSTATIN CREAM USP, 100,000 UNITS/GRAM VINTAGE PHARMACEUTICALS, LLC 5/31/2006 
21 65-356 DOXYCYCLINE TABLETS, 50 MG, 75 MG, AND 100 MG RANBAXY LABORATORIES LIMITED 5/31/2006 
22 77-681 LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS USP, 0.1 MG/0.02 MG; 28-DAY REGIMEN WATSON LABORATORIES, INC. 5/31/2006 
23 77-869 ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG INVAGEN PHARMACEUTICALS, INC. 5/31/2006 

 

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