FDA.reportPublic FDA data

Application 087425

Type
ANDA
Sponsor
HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISONIAZIDISONIAZIDTABLET;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-1261IsoniazidIsoniazidWest-Ward Pharmaceuticals CorpANDACurrent
0440-7655IsoniazidIsoniazidLiberty Pharmaceuticals, Inc.ANDACurrent
10544-087IsoniazidIsoniazidBlenheim Pharmacal, Inc.ANDACurrent
10544-121IsoniazidIsoniazidBlenheim Pharmacal, Inc.ANDACurrent
10544-218IsoniazidIsoniazidBlenheim Pharmacal, Inc.ANDACurrent
21695-627IsoniazidIsoniazidRebel Distributors CorpANDACurrent
52959-145IsoniazidIsoniazidH.J. Harkins Company, Inc.ANDACurrent
61748-013IsoniazidIsoniazidVersaPharm IncorporatedANDACurrent
68788-9116IsoniazidIsoniazidPreferred Pharmaceuticals, Inc.ANDACurrent