FDA.reportPublic FDA data

Application 078012

Type
ANDA
Sponsor
CARIBE HOLDINGS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24658-260GemfibrozilGemfibrozilPuraCap Laboratories LLC dba Blu PharmaceuticalsANDACurrent
24658-260GemfibrozilGemfibrozilPuraCap Laboratories LLC dba Blu PharmaceuticalsANDACurrent
42806-260GEMFIBROZILGEMFIBROZILEpic Pharma, LLCANDACurrent
42806-260GEMFIBROZILGEMFIBROZILEpic Pharma, LLCANDACurrent
42806-260GEMFIBROZILGEMFIBROZILEpic Pharma, LLCANDACurrent
43063-921GEMFIBROZILGEMFIBROZILPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-921GEMFIBROZILGEMFIBROZILPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-921GEMFIBROZILGEMFIBROZILPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-921GEMFIBROZILGEMFIBROZILPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-921GEMFIBROZILGEMFIBROZILPD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-772GemfibrozilGemfibrozilAphena Pharma Solutions - Tennessee, Inc.ANDACurrent
51013-811GEMFIBROZILGEMFIBROZILPuraCap Pharmaceutical, LLCANDACurrent
53808-0863GemfibrozilGemfibrozilState of Florida DOH Central PharmacyANDACurrent
60760-260GEMFIBROZILGEMFIBROZILSt. Mary's Medical Park PharmacyANDACurrent
71335-0051GEMFIBROZILGEMFIBROZILBryant Ranch PrepackANDACurrent
71335-0051GEMFIBROZILGEMFIBROZILBryant Ranch PrepackANDACurrent