FDA.reportPublic FDA data

Application 210614

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
0904-7080NifedipinenifedipineMajor PharmaceuticalsANDACurrent
0904-7080NifedipinenifedipineMajor PharmaceuticalsANDACurrent
0904-7081NifedipinenifedipineMajor PharmaceuticalsANDACurrent
0904-7081NifedipinenifedipineMajor PharmaceuticalsANDACurrent
0904-7081NifedipinenifedipineMajor PharmaceuticalsANDACurrent
0904-7082NifedipinenifedipineMajor PharmaceuticalsANDACurrent
0904-7082NifedipinenifedipineMajor PharmaceuticalsANDACurrent
0904-7082NifedipinenifedipineMajor PharmaceuticalsANDACurrent
50090-6201NifedipinenifedipineA-S Medication SolutionsANDACurrent
50090-6203NifedipinenifedipineA-S Medication SolutionsANDACurrent
50742-260NifedipinenifedipineIngenus Pharmaceuticals, LLCANDACurrent
50742-260NifedipinenifedipineIngenus Pharmaceuticals, LLCANDACurrent
50742-260NifedipinenifedipineIngenus Pharmaceuticals, LLCANDACurrent
50742-261NifedipinenifedipineIngenus Pharmaceuticals, LLCANDACurrent
50742-261NifedipinenifedipineIngenus Pharmaceuticals, LLCANDACurrent
50742-261NifedipinenifedipineIngenus Pharmaceuticals, LLCANDACurrent
50742-262NifedipinenifedipineIngenus Pharmaceuticals, LLCANDACurrent
50742-262NifedipinenifedipineIngenus Pharmaceuticals, LLCANDACurrent
50742-262NifedipinenifedipineIngenus Pharmaceuticals, LLCANDACurrent
55154-4157NifedipinenifedipineCardinal Health 107, LLCANDACurrent
68071-2619NifedipinenifedipineNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7642NifedipinenifedipinePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7642NifedipinenifedipinePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7642NifedipinenifedipinePreferred Pharmaceuticals, Inc.ANDACurrent
68788-8164NifedipinenifedipinePreferred Pharmaceuticals Inc.ANDACurrent
70518-2679NifedipinenifedipineREMEDYREPACK INC.ANDACurrent
70518-2679NifedipinenifedipineREMEDYREPACK INC.ANDACurrent
70518-2679NifedipinenifedipineREMEDYREPACK INC.ANDACurrent
70518-2679NifedipinenifedipineREMEDYREPACK INC.ANDACurrent
70518-3520NifedipinenifedipineREMEDYREPACK INC.ANDACurrent
70518-3520NifedipinenifedipineREMEDYREPACK INC.ANDACurrent
71335-1550NifedipinenifedipineBryant Ranch PrepackANDACurrent
71335-1550NifedipinenifedipineBryant Ranch PrepackANDACurrent
71335-1721NifedipinenifedipineBryant Ranch PrepackANDACurrent
71335-2132NifedipinenifedipineBryant Ranch PrepackANDACurrent