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U.S. Department of Health and Human Services

Drugs

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First-Time Generic Drug Approvals - August 2012

 Generic Drug NameGeneric ManufacturerBrand NameApproval Date
1MONTELUKAST SODIUM TABLETS, 10 MG (BASE)       ROXANE LABORATORIES, INC.SINGULAIR TABLETS8/3/2012 
2MONTELUKAST SODIUM CHEWABLE TABLETS, 4 MG (BASE) AND 5 MG (BASE)      MYLAN PHARMACEUTICALS, INC.SINGULAIR CHEWABLE TABLETS8/3/2012 
3MONTELUKAST SODIUM TABLETS, 10 MG (BASE)       GLENMARK GENERICS LIMITEDSINGULAIR TABLETS8/3/2012 
4MONTELUKAST SODIUM TABLETS, 10 MG (BASE)       KUDCO IRELAND LIMITEDSINGULAIR TABLETS8/3/2012 
5MONTELUKAST SODIUM CHEWABLE TABLETS, 4 MG (BASE) AND 5 MG (BASE)      KUDCO IRELAND LIMITEDSINGULAIR CHEWABLE TABLETS8/3/2012 
6MONTELUKAST SODIUM TABLETS, 10 MG (BASE)       ENDO PHARMACEUTICALS, INC.SINGULAIR TABLETS8/3/2012 
7MONTELUKAST SODIUM CHEWABLE TABLETS, 4 MG (BASE) AND 5 MG (BASE)      ENDO PHARMACEUTICALS, INC.SINGULAIR CHEWABLE TABLETS8/3/2012 
8MONTELUKAST SODIUM TABLETS, 10 MG (BASE)       AUROBINDO PHARMA LIMITEDSINGULAIR TABLETS8/3/2012 
9MONTELUKAST SODIUM CHEWABLE TABLETS, 4 MG (BASE) AND 5 MG (BASE)      AUROBINDO PHARMA LIMITEDSINGULAIR CHEWABLE TABLETS8/3/2012 
10MONTELUKAST SODIUM CHEWABLE TABLETS, 4 MG (BASE) AND 5 MG (BASE)      APOTEX INC.SINGULAIR CHEWABLE TABLETS8/3/2012 
11MONTELUKAST SODIUM ORAL GRANULES, 4 MG (BASE)/ SINGLE-DOSE PACKET      TEVA PHARMACEUTICALS USASINGULAIR ORAL GRANULES, 4 MG (BASE)8/3/2012 
12MONTELUKAST SODIUM CHEWABLE TABLETS, 4 MG (BASE) AND 5 MG (BASE)      TEVA PHARMACEUTICALS USASINGULAIR CHEWABLE TABLETS8/3/2012 
13MONTELUKAST SODIUM TABLETS, 10 MG (BASE)       MYLAN PHARMACEUTICALS, INC.SINGULAIR TABLETS8/3/2012 
14MONTELUKAST SODIUM TABLETS, 10 MG (BASE)       TEVA PHARMACEUTICALS USASINGULAIR TABLETS, 10 MG (BASE)8/3/2012 
15MONTELUKAST SODIUM CHEWABLE TABLETS, 4 MG (BASE) AND 5 MG (BASE)      ROXANE LABORATORIES, INC.SINGULAIR CHEWABLE TABLETS8/3/2012 
16MONTELUKAST SODIUM TABLETS,  10 MG (BASE)       SANDOZ, INC.SINGULAIR TABLETS, 10 MG (BASE)8/3/2012 
17MONTELUKAST SODIUM CHEWABLE TABLETS, 4 MG (BASE) AND 5 MG (BASE)      TORRENT PHARMACEUTICALS, LTD.SINGULAIR CHEWABLE TABLETS8/3/2012 
18MONTELUKAST SODIUM TABLETS, 10 MG (BASE)       TORRENT PHARMACEUTICALS LIMITEDSINGULAIR TABLETS8/3/2012 
19MONTELUKAST SODIUM TABLETS, 10 MG (BASE)       APOTEX INC.SINGULAIR TABLETS8/3/2012 
20DIDANOSINE TABLETS FOR ORAL SUSPENSION USP, 100 MG, 150 MG AND 200 MG     AUROBINDO PHARMA LIMITEDVIDEX TABLETS (CHEWABLE, DISPERSIBLE, BUFFERE8/14/2012 
21CLOBETASOL PROPIONATE FOAM (EMOLLIENT FORMULATION), 0.05%       PERRIGO ISRAEL PHARMACEUTICALS, LTD.OLUX E FOAM8/14/2012 
22PIOGLITAZONE TABLETS USP, 15 MG, 30 MG AND 45 MG     MYLAN PHARMACEUTICALS, INC.ACTOS TABLETS8/17/2012 
23MYCOPHENOLIC ACID DELAYED-RELEASE TABLETS, 180 MG       APOTEX CORP.MYFORTIC DELAYED-RELEASE TABLETS8/21/2012 
24NEDOCROMIL SODIUM OPHTHALMIC SOLUTION, 2%       AKORN INC.ALOCRIL OPHTHALMIC SOLUTION8/22/2012 
25LIDOCAINE PATCH, 5%       WATSON LABORATORIES, INC.LIDODERM PATCH8/23/2012 
26ARMODAFINIL TABLETS, 100 MG AND 200 MG      WATSON LABORATORIES, INC.NUVIGIL TABLETS8/29/2012 
27AZELASTINE HYDROCHLORIDE NASAL SOLUTION, (NASAL SPRAY), 0.15% [0.187 MG (BASE)/SPRAY]     APOTEX INC.ASTEPRO NASAL SPRAY8/31/2012