FDA.reportPublic FDA data

Application 077169

Type
ANDA
Sponsor
ELITE LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISRADIPINEISRADIPINECAPSULE;ORAL2.5MGNoNo
002ISRADIPINEISRADIPINECAPSULE;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42806-263IsradipineIsradipineEpic Pharma, LLCANDACurrent
42806-263IsradipineIsradipineEpic Pharma, LLCANDACurrent
42806-264IsradipineIsradipineEpic Pharma, LLCANDACurrent
42806-264IsradipineIsradipineEpic Pharma, LLCANDACurrent
60429-385IsradipineIsradipineGolden State Medical Supply, Inc.ANDACurrent
60429-385IsradipineIsradipineGolden State Medical Supply, Inc.ANDACurrent
60429-386IsradipineIsradipineGolden State Medical Supply, Inc.ANDACurrent
60429-386IsradipineIsradipineGolden State Medical Supply, Inc.ANDACurrent
64850-910IsradipineIsradipineElite Laboratories, Inc.ANDACurrent
64850-911IsradipineIsradipineElite Laboratories, Inc.ANDACurrent
68462-807IsradipineIsradipineGlenmark Pharmaceuticals Inc.,USAANDACurrent
68462-807IsradipineIsradipineGlenmark Pharmaceuticals Inc.,USAANDACurrent
68462-808IsradipineIsradipineGlenmark Pharmaceuticals Inc.,USAANDACurrent
68462-808IsradipineIsradipineGlenmark Pharmaceuticals Inc.,USAANDACurrent