FDA.reportPublic FDA data

Application 203126

Type
ANDA
Sponsor
TWI PHARMS

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
0904-7208NifedipineNifedipineMajor PharmaceuticalsANDACurrent
0904-7208NifedipineNifedipineMajor PharmaceuticalsANDACurrent
24979-009NifedipineNifedipineTWi Pharmaceuticals, Inc.ANDACurrent
24979-009NifedipineNifedipineTWI Pharmaceuticals, Inc.ANDACurrent
24979-009NifedipineNifedipineTWI Pharmaceuticals, Inc.ANDACurrent
24979-009NifedipineNifedipineTWi Pharmaceuticals, Inc.ANDACurrent
24979-009NifedipineNifedipineTWi Pharmaceuticals, Inc.ANDACurrent
24979-009NifedipineNifedipineTWi Pharmaceuticals, Inc.ANDACurrent
24979-009NifedipineNifedipineTWI Pharmaceuticals, Inc.ANDACurrent
24979-009NifedipineNifedipineTWI Pharmaceuticals, Inc.ANDACurrent
24979-010NifedipineNifedipineTWI Pharmaceuticals, Inc.ANDACurrent
24979-010NifedipineNifedipineTWI Pharmaceuticals, Inc.ANDACurrent
24979-010NifedipineNifedipineTWI Pharmaceuticals, Inc.ANDACurrent
24979-010NifedipineNifedipineTWi Pharmaceuticals, Inc.ANDACurrent
24979-010NifedipineNifedipineTWi Pharmaceuticals, Inc.ANDACurrent
24979-010NifedipineNifedipineTWi Pharmaceuticals, Inc.ANDACurrent
24979-010NifedipineNifedipineTWI Pharmaceuticals, Inc.ANDACurrent
24979-010NifedipineNifedipineTWi Pharmaceuticals, Inc.ANDACurrent
24979-011NifedipineNifedipineTWi Pharmaceuticals, Inc.ANDACurrent
24979-011NifedipineNifedipineTWI Pharmaceuticals, Inc.ANDACurrent
24979-011NifedipineNifedipineTWI Pharmaceuticals, Inc.ANDACurrent
24979-011NifedipineNifedipineTWi Pharmaceuticals, Inc.ANDACurrent
24979-011NifedipineNifedipineTWi Pharmaceuticals, Inc.ANDACurrent
24979-011NifedipineNifedipineTWI Pharmaceuticals, Inc.ANDACurrent
24979-011NifedipineNifedipineTWI Pharmaceuticals, Inc.ANDACurrent
24979-011NifedipineNifedipineTWi Pharmaceuticals, Inc.ANDACurrent
50090-1843NifedipineNifedipineA-S Medication SolutionsANDACurrent
50090-1843NifedipineNifedipineA-S Medication SolutionsANDACurrent
50090-5328NifedipineNifedipineA-S Medication SolutionsANDACurrent
50090-5328NifedipineNifedipineA-S Medication SolutionsANDACurrent
50090-5328NifedipineNifedipineA-S Medication SolutionsANDACurrent
55700-401NifedipineNifedipineLake Erie Medical DBA Quality Care Products LLCANDACurrent
60429-047NifedipineNifedipineGolden State Medical SupplyANDACurrent
60429-047NifedipineNifedipineGolden State Medical Supply, Inc.ANDACurrent
60429-047NifedipineNifedipineGolden State Medical SupplyANDACurrent
60429-047NifedipineNifedipineGolden State Medical SupplyANDACurrent
60429-047NifedipineNifedipineGolden State Medical SupplyANDACurrent
60429-048NifedipineNifedipineGolden State Medical SupplyANDACurrent
60429-048NifedipineNifedipineGolden State Medical SupplyANDACurrent
60429-048NifedipineNifedipineGolden State Medical SupplyANDACurrent
60429-048NifedipineNifedipineGolden State Medical SupplyANDACurrent
60429-048NifedipineNifedipineGolden State Medical Supply, Inc.ANDACurrent
60429-049NifedipineNifedipineGolden State Medical Supply, Inc.ANDACurrent
60429-049NifedipineNifedipineGolden State Medical SupplyANDACurrent
60429-049NifedipineNifedipineGolden State Medical SupplyANDACurrent
60429-049NifedipineNifedipineGolden State Medical SupplyANDACurrent
60429-049NifedipineNifedipineGolden State Medical SupplyANDACurrent
61919-192NIFEDIPINENIFEDIPINEDIRECT RXANDACurrent
61919-192NIFEDIPINENIFEDIPINEDIRECT RXANDACurrent
61919-319NIFEDIPINENIFEDIPINEDIRECT RXANDACurrent
61919-319NIFEDIPINENIFEDIPINEDIRECT RXANDACurrent
66267-322NifedipineNifedipineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-322NifedipineNifedipineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-508NifedipineNifedipineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-508NifedipineNifedipineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-684NifedipineNifedipineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-684NifedipineNifedipineNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3281NIFEdipineNIFEdipineNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3281NIFEdipineNIFEdipineNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3281NIFEdipineNIFEdipineNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3347NifedipineNifedipineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3347NifedipineNifedipineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3347NifedipineNifedipineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4097NifedipineNifedipineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4097NifedipineNifedipineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4097NifedipineNifedipineNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6773NifedipineNifedipinePreferred Pharmaceuticals, Inc.ANDACurrent
68788-6971NifedipineNifedipinePreferred Pharmaceuticals, Inc.ANDACurrent
68788-6971NifedipineNifedipinePreferred Pharmaceuticals, Inc.ANDACurrent
68788-6971NifedipineNifedipinePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0694NifedipineNifedipineREMEDYREPACK INC.ANDACurrent
70518-0694NifedipineNifedipineREMEDYREPACK INC.ANDACurrent
70934-577NifedipineNifedipineDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-603NifedipineNifedipineDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-604NifedipineNifedipineDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-412NifedipineNifedipineProficient Rx LPANDACurrent
71205-963NifedipineNifedipineProficient Rx LPANDACurrent
71205-963NifedipineNifedipineProficient Rx LPANDACurrent
71205-963NifedipineNifedipineProficient Rx LPANDACurrent
71205-964NifedipineNifedipineProficient Rx LPANDACurrent