FDA.reportPublic FDA data

Application 203266

Type
ANDA
Sponsor
CADILA PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GEMFIBROZILGEMFIBROZILTABLET;ORAL600MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68071-2296GemfibrozilGemfibrozilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2296GemfibrozilGemfibrozilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4421GemfibrozilGemfibrozilNuCare Pharmaceuticals,Inc.ANDACurrent
70934-466GemfibrozilGemfibrozilDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-466GemfibrozilGemfibrozilDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71209-008GemfibrozilGemfibrozilCadila Pharmaceuticals LimitedANDACurrent
71209-008GemfibrozilGemfibrozilCadila Pharmaceuticals LimitedANDACurrent
71209-008GemfibrozilGemfibrozilCadila Pharmaceuticals LimitedANDACurrent
71209-008GemfibrozilGemfibrozilCadila Pharmaceuticals LimitedANDACurrent
71209-008GemfibrozilGemfibrozilCadila Pharmaceuticals LimitedANDACurrent
71335-1902GemfibrozilGemfibrozilBryant Ranch PrepackANDACurrent
71335-1902GemfibrozilGemfibrozilBryant Ranch PrepackANDACurrent
75834-131GemfibrozilGemfibrozilNivagen Pharmaceuticals, Inc.ANDACurrent
75834-131GemfibrozilGemfibrozilNivagen Pharmaceuticals, Inc.ANDACurrent
75834-131GemfibrozilGemfibrozilNivagen Pharmaceuticals, Inc.ANDACurrent