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U.S. Department of Health and Human Services

Drugs

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Approvals - August 2006

  ANDA Number Generic Drug Name Applicant Approval Date
  77-361 TRIMIPRAMINE MALEATE CAPSULES 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)   AMIDE PHARMACEUTICAL, INC. 8/2/2006 
2 76-690 VENLAFAXINE HYDROCHLORIDE TABLETS 25 MG (BASE), 37.5 MG (BASE), 50 MG (BASE), 75 MG (BASE), AND 100 MG (BASE)   TEVA PHARMACEUTICALS USA 8/3/2006 
3 77-704 FLUNISOLIDE NASAL SOLUTION USP, 0.025% (0.025 MG/SPRAY) METERED NASAL SPRAY   Q-PHARMA LLC 8/3/2006 
4 77-051 FENTANYL TRANSDERMAL SYSTEM 25 MCG/HOUR, 50 MCG/HOUR, 75 MCG/HOUR, AND 100 MCG/HOUR   LAVIPHARM LABORATORIES, INC. 8/4/2006 
5 40-615 TESTOSTERONE CYPIONATE INJECTION USP, 100 MG/ML AND 200 MG/ML   SANDOZ CANADA, INC. 8/10/2006 
6 65-292 CEFOTAXIME FOP INJECTION USP, 10 G (BASE)/VIAL (PHARMACY BULK PACKAGE)   ORCHID HEALTHCARE 8/10/2006 
7 65-293 CEFOTAXIME FOR INJECTION USP, 1 G(BASE)/VIAL AND 2 G(BASE)/VIAL PACKAGED IN INFUSION BOTTLES   ORCHID HEALTHCARE 8/10/2006 
8 65-290 CEFOTAXIME FOR INJECTION USP, 500 MG (BASE)/VIAL, 1 G (BASE)/VIAL, AND 2 G (BASE)/VIAL   ORCHID HEALTHCARE 8/11/2006 
9 76-465 SERTRALINE HYDROCHLORIDE TABLETS 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)   TEVA PHARMACEUTICALS USA 8/11/2006 
10 77-393 STERILE WATER FOR INJECTION USP, PACKAGED IN SINGLE-DOSE PLASTIC AMPULES   TARO PHARMACEUTICALS IRELAND LTD. 8/11/2006 
11 77-407 SODIUM CHLORIDE INJECTION USP, 0.9% PACKAGED IN 5 ML & 10 ML SINGLE-DOSE PLASTIC AMPULES   TARO PHARMACEUTICALS IRELAND LTD. 8/11/2006 
12 77-628 IBUPROFEN AND PSEUROEPHEDRINE HYDROCHLORIDE TABLETS USP, 200 MG/30 MG (OTC)   DR. REDDY'S LABORATORIES LIMITED 8/14/2006 
13 77-705 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG AND 20 MG/12.5 MG   GENPHARM INC. 8/14/2006 
14 77-862 BACLOFEN TABLETS USP, 20 MG   CARACO PHARMACEUTICAL LABORATORIES, LTD. 8/14/2006 
15 77-984 BACLOFEN TABLETS USP, 10 MG   CARACO PHARMACEUTICAL LABORATORIES, LTD. 8/14/2006 
16 77-813 ZONISAMIDE CAPSULES 25 MG, 50 MG, AND 100 MG   BANNER PHARMACAPS, INC. 8/16/2006 
17 76-626 NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS 0.18 MG/0.035 MG, 0.215 MG/0.035 MG, AND 0.25 MG/0.035 MG, RESPECTIVELY; PACKAGED IN A 28-DAY CYCLE REGIMEN   WATSON LABORATORIES, INC. 8/17/2006 
18 76-627 NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS 0.25 MG/0.035 MG, RESPECTIVELY; PACKAGED IN A 28-DAY CYCLE REGIMEN   WATSON LABORATORIES, INC. 8/17/2006 
19 65-321 NYSTATIN TOPICAL POWDER USP, 100,000 UNITS/GRAM   KV PHARMACEUTICAL COMPANY 8/18/2006 
20 77-662 GABAPENTIN TABLETS 600 MG AND 800 MG   GLENMARK PHARMACEUTICALS LIMITED 8/18/2006 
21 77-787 METFORMIN HYDROCHLORIDE TABLETS USP, 500 MG, 850 MG, AND 1000 MG   DR. REDDY'S LABORATORIES LTD. 8/23/2006 
22 77-242 GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400 MG   SUN PHARMACEUTICAL INDUSTRIES LTD. 8/24/2006 
23 77-525 GABAPENTIN TABLETS 600 MG AND 800 MG   SUN PHARMACEUTICAL INDUSTRIES LTD. 8/24/2006 
24 40-729 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, 5 MG/500 MG   INTERPHARM INC. 8/25/2006 
25 40-736 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, 5 MG/325 MG   INTERPHARM INC. 8/25/2006 
26 40-746 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, 10 MG/325 MG   INTERPHARM INC. 8/25/2006 
27 40-748 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, 7.5 MG/500 MG   INTERPHARM INC. 8/25/2006 
28 40-754 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, 7.5 MG/650 MG   INTERPHARM INC. 8/25/2006 
29 40-757 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, 10 MG/650 MG   INTERPHARM INC. 8/25/2006 
30 40-769 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, 7.5 MG/750 MG   INTERPHARM INC. 8/28/2006 
31 76-484 CIPROFLOXACIN INJECTION USP, 10 MG/ML, PACKAGED IN 200 MG/20 ML AND 400 MG/40 ML SINGLE-USE VIALS   ABRAXIS PHARMACEUTICAL PRODUCTS 8/28/2006 
32 76-992 CIPROFLOXACIN INJECTION USP, 10 MG/ML; PACKAGED IN 200 MG/20 ML AND 400 MG/40 ML SINGLE-DOSE VIALS   BEDFORD LABORATORIES 8/28/2006 
33 76-993 CIPROFLOXACIN INJECTION USP, 10 MG/ML; PACKAGED IN 1200 MG/120 ML SINGLE-USE VIAL; PHARMACY BULK PACKAGE   BEDFORD LABORATORIES 8/28/2006 
34 77-245 CIPROFLOXACIN INJECTION USP, 10 MG/ML; PACKAGED IN 200 MG/20 ML AND 400 MG/40 ML SINGLE-USE VIALS   HOSPIRA INC. 8/28/2006 
35 77-782 CIPROFLOXACIN INJECTION USP, 10 MG/ML; PACKAGED IN 200 MG/20 ML AND 400 MG/40 ML SINGLE-USE VIALS   SICOR PHARMACEUTICALS, INC. 8/28/2006 
36 77-812 CITALOPRAM HYDROBROMIDE ORAL SOLUTION 10 MG (BASE)/5 ML   AUROBINDO PHARMA LIMITED 8/28/2006 
37 77-878 METOCLOPRAMIDE TABLETS USP, 5 MG AND 10 MG   VINTAGE PHARMACEUTICALS, LLC 8/28/2006 
38 40-750 SPIRONOLACTONE TABLETS USP, 25 MG, 50 MG, AND 100 MG   VINTAGE PHARMACEUTICALS, LLC 8/29/2006 
39 65-197 CEFOTAXIME FOR INJECTION USP, 1 GRAM/VIAL   WOCKHARDT LIMITED 8/29/2006 
40 76-388 LAMOTRIGINE TABLETS 25 MG, 100 MG, 150 MG, AND 200 MG   TEVA PHARMACEUTICALS USA 8/30/2006 
41 40-653 GLYCOPYRROLATE TABLETS 1 MG AND 2 MG   KALI LABORATORIES, INC. 8/31/2006 
42 77-531 FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG, AND 40 MG   COBALT PHARMACEUTICALS, INC. 8/31/2006

 

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