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U.S. Department of Health and Human Services

Drugs

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First-Time Generic Drug Approvals - May 2012

 Generic Drug NameGeneric ManufacturerBrand NameApproval Date
1VARDENAFIL HYDORCHLORIDE TABLETS, 2.5 MG, 5 MG, 10 MG AND 20 MG    TEVA PHARMACUTICALS USALEVITRA TABLETS5/3/2012 
2CARBIDOPA, LEVODOPA AND ENTACAPONE TABLETS, 25 MG/100 MG/200 MG AND 37.5 MG/150 MG/200 MG      SUN PHARMA GLOBAL FZESTALEVO TABLETS5/10/2012 
3CLOPIDOGREL TABLETS USP, 75 MG       AUROBINDO PHARMA LIMITEDPLAVIX TABLETS 75 MG5/17/2012 
4CLOPIDOGREL TABLETS USP, 300 MG       TEVA PHARMACEUTICALS USAPLAVIX TABLETS5/17/2012 
5CLOPIDOGREL TABLETS USP, 75 MG       SUN PHARMA GLOBAL FZEPLAVIX TABLETS5/17/2012 
6CLOPIDOGREL TABLETS USP, 75 MG       TORRENT PHARMACEUTICALS LIMITEDPLAVIX TABLETS5/17/2012 
7CLOPIDOGREL TABLETS USP, 75 MG AND 300 MG      MYLAN PHARMACEUTICALS, INC.PLAVIX TABLETS5/17/2012 
8CLOPIDOGREL TABLETS USP, 75 MG       TEVA PHARMACEUTICALS USAPLAVIX TABLETS 75 MG5/17/2012 
9CLOPIDOGREL TABLETS USP, 300 MG 300 MG       GATE PHARMACEUTICALSPLAVIX TABLETS 300 MG5/17/2012 
10CLOPIDOGREL TABLETS USP, 75 MG       ROXANE LABORATORIES, INC.PLAVIX TABLETS 75 MG5/17/2012 
11CLOPIDOGREL TABLETS USP, 300 MG       DR. REDDY'S LABORATORIES LIMITEDPLAVIX TABLETS 300 MG5/17/2012 
12ROPINIROLE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 4 MG (BASE), 6 MG (BASE), 8 MG (BASE) AND 12 MG (BASE)    ACTAVIS SOUTH ATLANTIC LLC.REQUIP XL TABLETS5/17/2012 
13CLOPIDOGREL TABLETS USP, 75 MG       APOTEX INC.PLAVIX TABLETS 75 MG5/17/2012 
14BUTOCONAZOLE NITRATE VAGINAL CREAM USP, 2%       PERRIGO ISRAEL PHARMACEUTICALS, LTD.GYNAZOLE-1 VAGINAL CREAM5/18/2012 
15LANSOPRAZOLE DELAYED-RELEASE CAPSULES USP, (OTC) 15 MG       PERRIGO R&D COMPANYPREVACID 24 HOUR DELAYED-RELEASE CAPSULES5/18/2012 
16LANSOPRAZOLE DELAYED-RELEASE CAPSULES USP, (OTC) 15 MG       DR. REDDY'S LABORATORIES LIMITEDPREVACID 24 HOUR DELAYED-RELEASE CAPSULES5/18/2012 
17LANSOPRAZOLE DELAYED-RELEASE CAPSULES USP, (OTC) 15 MG       WOCKHARDT LIMITEDPREVACID 24 HOUR5/18/2012 
18MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS 65 MG (BASE) 115 MG (BASE)      BARR LABORATORIES, INC.SOLODYN EXTENDED-RELEASE TABLETS5/18/2012 
19NEVIRAPINE TABLETS USP, 200 MG       MICRO LABS LIMITED, INDIAVIRAMUNE TABLETS5/22/2012 
20NEVIRAPINE TABLETS USP, 200 MG       CIPLA LIMITEDVIRAMUNE TABLETS5/22/2012 
21NEVIRAPINE TABLETS USP, 200 MG       AUROBINDO PHARMA LIMITEDVIRAMUNE TABLETS5/22/2012 
22NEVIRAPINE ORAL SUSPENSION USP, 50 MG/5 ML       AUROBINDO PHARMA LIMITEDVIRAMUNE ORAL SUSPENSION5/22/2012 
23NEVIRAPINE TABLETS USP, 200 MG       HETERO LABS LIMITED, UNIT IIIVIRAMUNE TABLETS5/22/2012 
24NEVIRAPINE TABLETS USP, 200 MG       PRINSTON PHARMACEUTICAL, INC.VIRAMUNE TABLETS5/22/2012 
25NEVIRAPINE TABLETS USP, 200 MG       MYLAN LABORATORIES, LTD.VIRAMUNE TABLETS5/22/2012 
26NEVIRAPINE TABLETS USP, 200 MG       SCIEGEN PHARMACEUTICALS, INC.VIRAMUNE TABLETS5/22/2012 
27NEVIRAPINE TABLETS USP, 200 MG       MYLAN PHARMACEUTICALS, INC.VIRAMUNE TABLETS5/22/2012 
28NEVIRAPINE TABLETS USP, 200 MG       APOTEX INC.VIRAMUNE TABLETS5/22/2012 
29NEVIRAPINE TABLETS USP, 200 MG       STRIDES ARCOLAB LIMITEDVIRAMUNE TABLETS5/22/2012 
30DEXTROMETHORPHAN POLISTIREX EXTENDED-RELEASE SUSPENSION, 30 MG/5 ML       TRIS PHARMA, INC.DELSYM EXTENDED-RELEASE COUGH SUPPRESSANT5/25/2012 
31CALCIPOTRIENE CREAM, 0.005%       TOLMAR INC.DOVONEX CREAM5/30/2012 
32VORICONAZOLE FOR INJECTION, 200 MG SINGLE-DOSE VIALS      SANDOZ INC.VFEND I.V. FOR INJECTION5/30/2012