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U.S. Department of Health and Human Services

Drugs

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First-Time Generic Drug Approvals - February 2014

 Generic Drug NameGeneric ManufacturerBrand NameTentative Approval DateApproval Date
1
AZITHROMYCIN OPHTHALMIC SOLUTION, 1%       
SANDOZ INC.
AZASITE OPHTHALMIC SOLUTION
2/24/2014 
 
2
FLUOXETINE TABLETS USP, 10 MG, 15 MG AND 20 MG     
TEVA PHARMACEUTICALS USA
SARAFEM TABLETS
 
2/3/2014 
3
PRIMAQUINE PHOSPHATE TABLETS USP, 26.3 MG (15 MG BASE)       
ALVOGEN INC.
PRIMAQUINE TABLETS
 
2/3/2014 
4
PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS, 0.375 MG, 0.75 MG, 1.5 MG, 2.25 MG, 3 MG, 3.75 MG AND 4.5 MG 
ANCHEN PHARMACEUTICALS, INC.
MIRAPEX ER EXTENDED-RELEASE TABLETS
 
2/6/2014 
5
KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION, 0.45%       
AKORN INC.
ACUVAIL OPHTHALMIC SOLUTION
 
2/10/2014 
6
IBANDRONATE SODIUM INJECTION, 1 MG (BASE)/ML; PACKAGED IN 3 ML SINGLE-DOSE VIALS      
SUN PHARMACEUTICAL INDUSTRIES LTD.
BONIVA INJECTION
 
2/14/2014 
7
MOXIFLOXACIN HYDROCHLORIDE TABLETS, 400 MG (BASE)       
TEVA PHARMACEUTICALS USA
AVELOX TABLETS
 
2/18/2014 
8
RIFABUTIN CAPSULES USP, 150 MG       
LUPIN LIMITED
MYCOBUTIN CAPSULES
 
2/24/2014 
9
TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP, 40 MG/12.5 MG, 80 MG/12.5 MG AND 80 MG/25 MG     
MYLAN PHARMACEUTICALS, INC.
MICARDIS HCT TABLETS
 
2/25/2014 
10
TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP, 40 MG/12.5 MG, 80 MG/12.5 MG AND 80 MG/25 MG     
ALEMBIC PHARMACEUTICALS LIMITED
MICARDIS HCT TABLETS
 
2/25/2014 
11
TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP, 40 MG/12.5 MG, 80 MG/12.5 MG AND 80 MG/25 MG     
TORRENT PHARMACEUTICALS LIMITED
MICARDIS HCT TABLETS
 
2/25/2014 
12
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES, 0.5 MG/0.4 MG       
ANCHEN PHARMACEUTICALS, INC.
JALYN CAPSULES
 
2/26/2014