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U.S. Department of Health and Human Services

Drugs

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First-Time Generic Drug Approvals - December 2012

 Generic Drug NameGeneric ManufacturerBrand NameApproval Date
1CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS, 16 MG/12.5 MG, 32 MG/12.5 MG AND 32 MG/25 MG     MYLAN PHARMACEUTICALS, INC.ATACAND-HCT TABLETS12/4/2012 
2AMMONIA N 13 INJECTION USP, 3.75 - 260 mCi/ML at EOS       HOUSTON CYCLOTRON PARTNERS LPAMMONIA N 13 INJECTION USP, 3.75-35.5 mCi at12/14/2012 
3LAMOTRIGINE EXTENDED-RELEASE TABLETS, (ONCE A DAY) 25 MG, 50 MG, 100 MG, 200 MG, 250 MG AND 300 MG  ANCHEN PHARMACEUTICALS, INC.LAMICTAL XR EXTENDED-RELEASE TABLETS12/26/2012 
4PHENYTOIN CHEWABLE TABLETS USP, 50 MG       MYLAN PHARMACEUTICALS, INC.DILANTIN CHEWABLE TABLETS12/26/2012 
5SODIUM FLUORIDE F-18 INJECTION USP, 10-200 mCi/mL AT EOS       HOUSTON CYCLOTRON PARTNERS LPSODIUM FLUORIDE F-18 INJECTION, USP12/26/2012 
6TRANEXAMIC ACID TABLETS, 650 MG       WATSON LABORATORIES, INC. - FLORIDALYSTEDA TABLETS12/27/2012 
7METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP, 27 MG, 36 MG AND 54 MG     MALLINCKRODT INC.CONCERTA EXTENDED-RELEASE TABLETS12/28/2012 
8RIZATRIPTAN BENZOATE TABLETS, 5 MG (BASE) AND 10 MG (BASE)      SANDOZ INC.MAXALT TABLETS12/31/2012 
9RIZATRIPTAN BENZOATE TABLETS, 5 MG (BASE) AND 10 MG (BASE)      MYLAN PHARMACEUTICALS, INC.MAXALT TABLETS12/31/2012 
10RIZATRIPTAN BENZOATE TABLETS, 5 MG (BASE) AND 10 MG (BASE)      NATCO PHARMA LIMITEDMAXALT TABLETS12/31/2012 
11RIZATRIPTAN BENZOATE TABLETS, 5 MG (BASE) AND 10 MG (BASE)      AUROBINDO PHARMA LIMITEDMAXALT TABLETS12/31/2012 
12RIZATRIPTAN BENZOATE TABLETS, 5 MG (BASE) AND 10 MG (BASE)      GLENMARK GENERICS LIMITEDMAXALT TABLETS12/31/2012 
13RIZATRIPTAN BENZOATE TABLETS, 5 MG (BASE) AND 10 MG (BASE)      SUN PHARMA GLOBAL FZEMAXALT TABLETS12/31/2012 
14RIZATRIPTAN BENZOATE TABLETS, 5 MG (BASE) AND 10 MG (BASE)      TEVA PHARNACEUTICALS USA, INC.MAXALT TABLETS12/31/2012 
15RIZATRIPTAN BENZOATE TABLETS, 5 MG (BASE) AND 10 MG (BASE)      APOTEX INC.MAXALT TABLETS12/31/2012 
16RIZATRIPTAN BENZOATE ORALLY DISINTEGRATING TABLETS, 5 MG (BASE) AND 10 MG (BASE)      MYLAN PHARMACEUTICALS, INC.MAXALT-MLT ORALLY DISINTEGRATING TABLETS12/31/2012 

 

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