FDA.reportPublic FDA data

Application 077317

Type
ANDA
Sponsor
WATSON LABS TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISRADIPINEISRADIPINECAPSULE;ORAL2.5MGNoNo
002ISRADIPINEISRADIPINECAPSULE;ORAL5MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16252-539IsradipineIsradipineActavis Pharma, Inc.ANDACurrent
16252-539IsradipineIsradipineActavis Pharma, Inc.ANDACurrent
16252-540IsradipineIsradipineActavis Pharma, Inc.ANDACurrent
16252-540IsradipineIsradipineActavis Pharma, Inc.ANDACurrent
50268-454IsradipineIsradipineAvPAKANDACurrent
50268-454IsradipineIsradipineAvPAKANDACurrent
50268-455IsradipineIsradipineAvPAKANDACurrent
50268-455IsradipineIsradipineAvPAKANDACurrent
50268-455IsradipineIsradipineAvPAKANDACurrent
68151-1333IsradipineIsradipineCarilion Materials ManagementANDACurrent