FDA.reportPublic FDA data

Application 202987

Type
ANDA
Sponsor
NOVAST LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NIFEDIPINENIFEDIPINETABLET, EXTENDED RELEASE;ORAL30MGNoNo
002NIFEDIPINENIFEDIPINETABLET, EXTENDED RELEASE;ORAL60MGNoNo
003NIFEDIPINENIFEDIPINETABLET, EXTENDED RELEASE;ORAL90MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4249NifedipinenifedipineA-S Medication SolutionsANDACurrent
50090-4249NifedipinenifedipineA-S Medication SolutionsANDACurrent
50090-4442NifedipinenifedipineA-S Medication SolutionsANDACurrent
50090-4442NifedipinenifedipineA-S Medication SolutionsANDACurrent
50742-620NifedipinenifedipineIngenus Pharmaceuticals, LLCANDACurrent
50742-620NifedipinenifedipineIngenus Pharmaceuticals, LLCANDACurrent
50742-620NifedipinenifedipineIngenus Pharmaceuticals, LLCANDACurrent
50742-621NifedipinenifedipineIngenus Pharmaceuticals, LLCANDACurrent
50742-621NifedipinenifedipineIngenus Pharmaceuticals, LLCANDACurrent
50742-621NifedipinenifedipineIngenus Pharmaceuticals, LLCANDACurrent
50742-622NifedipinenifedipineIngenus Pharmaceuticals, LLCANDACurrent
50742-622NifedipinenifedipineIngenus Pharmaceuticals, LLCANDACurrent
50742-622NifedipinenifedipineIngenus Pharmaceuticals, LLCANDACurrent
51407-622NifedipinenifedipineGolden State Medical Supply, Inc.ANDACurrent
51407-623NifedipinenifedipineGolden State Medical Supply, Inc.ANDACurrent
51407-624NifedipinenifedipineGolden State Medical Supply, Inc.ANDACurrent
53808-1118NifedipinenifedipineDOH CENTRAL PHARMACYANDACurrent
68071-4334NifedipinenifedipineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4334NifedipinenifedipineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4334NifedipinenifedipineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4411NifedipinenifedipineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4411NifedipinenifedipineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4411NifedipinenifedipineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4558NifedipinenifedipineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4558NifedipinenifedipineNuCare Pharmaceuticals,Inc.ANDACurrent
70518-2089NifedipinenifedipineREMEDYREPACK INC.ANDACurrent
70934-973NifedipinenifedipineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent