FDA.reportPublic FDA data

Application 072781

Type
ANDA
Sponsor
INTERGEL PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NIFEDIPINENIFEDIPINECAPSULE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42192-615NifedipineNifedipineAcella Pharmaceuticals, LLCANDACurrent
43386-440NifedipineNifedipineLupin Pharmaceuticals IncANDACurrent
50268-591NifedipineNifedipineAvPAKANDACurrent
50268-591NifedipineNifedipineAvPAKANDACurrent
55154-8199NifedipineNifedipineCardinal HealthANDACurrent
55289-907NifedipineNifedipinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-907NifedipineNifedipinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-907NifedipineNifedipinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-907NifedipineNifedipinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-907NifedipineNifedipinePD-Rx Pharmaceuticals, Inc.ANDACurrent
60429-163NifedipineNifedipineGolden State Medical Supply, Inc.ANDACurrent
60429-163NifedipineNifedipineGolden State Medical Supply, Inc.ANDACurrent
60687-425NifedipineNifedipineAmerican Health PackagingANDACurrent
60687-425NifedipineNifedipineAmerican Health PackagingANDACurrent
60687-425NifedipineNifedipineAmerican Health PackagingANDACurrent
62112-8045NifedipineNifedipineIntergel Pharmaceuticals IncANDACurrent
62112-8045NifedipineNifedipineIntergel Pharmaceuticals IncANDACurrent
66267-831NifedipineNifedipineNuCare Pharmaceuticals,Inc.ANDACurrent
66267-831NifedipineNifedipineNuCare Pharmaceuticals,Inc.ANDACurrent
67296-1240NifedipineNifedipineRedPharm Drug, Inc.ANDACurrent
67296-1240NifedipineNifedipineRedPharm Drug, Inc.ANDACurrent
68151-2870NifedipineNifedipineCarilion Materials ManagementANDACurrent