FDA.reportPublic FDA data

Application 080212

Type
ANDA
Sponsor
HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISONIAZIDISONIAZIDTABLET;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-1260IsoniazidIsoniazidWest-Ward Pharmaceuticals CorpANDACurrent
55289-055IsoniazidIsoniazidPD-Rx Pharmaceuticals, Inc.ANDACurrent
61748-016IsoniazidIsoniazidVersaPharm IncorporatedANDACurrent