FDA.reportPublic FDA data

Application 208831

Type
ANDA
Sponsor
AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATINTABLET;ORAL10MG;10MGNoNo
002EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATINTABLET;ORAL10MG;20MGNoNo
003EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATINTABLET;ORAL10MG;40MGNoNo
004EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATINTABLET;ORAL10MG;80MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-078Ezetimibe and SimvastatinEzetimibe and SimvastatinAvKAREANDACurrent
42291-079Ezetimibe and SimvastatinEzetimibe and SimvastatinAvKAREANDACurrent
42291-080Ezetimibe and SimvastatinEzetimibe and SimvastatinAvKAREANDACurrent
42291-081Ezetimibe and SimvastatinEzetimibe and SimvastatinAvKAREANDACurrent
50090-3984Ezetimibe and SimvastatinEzetimibe and SimvastatinA-S Medication SolutionsANDACurrent
60219-1155Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1156Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1157Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1158Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals NY LLCANDACurrent
62559-700Ezetimibe and SimvastatinEzetimibe and SimvastatinANI Pharmaceuticals, Inc.ANDACurrent
62559-700Ezetimibe and SimvastatinEzetimibe and SimvastatinANI Pharmaceuticals, Inc.ANDACurrent
62559-700Ezetimibe and SimvastatinEzetimibe and SimvastatinANI Pharmaceuticals, Inc.ANDACurrent
62559-700Ezetimibe and SimvastatinEzetimibe and SimvastatinANI Pharmaceuticals, Inc.ANDACurrent
62559-700Ezetimibe and SimvastatinEzetimibe and SimvastatinANI Pharmaceuticals, Inc.ANDACurrent
62559-701Ezetimibe and SimvastatinEzetimibe and SimvastatinANI Pharmaceuticals, Inc.ANDACurrent
62559-701Ezetimibe and SimvastatinEzetimibe and SimvastatinANI Pharmaceuticals, Inc.ANDACurrent
62559-701Ezetimibe and SimvastatinEzetimibe and SimvastatinANI Pharmaceuticals, Inc.ANDACurrent
62559-701Ezetimibe and SimvastatinEzetimibe and SimvastatinANI Pharmaceuticals, Inc.ANDACurrent
62559-701Ezetimibe and SimvastatinEzetimibe and SimvastatinANI Pharmaceuticals, Inc.ANDACurrent
62559-702Ezetimibe and SimvastatinEzetimibe and SimvastatinANI Pharmaceuticals, Inc.ANDACurrent
62559-702Ezetimibe and SimvastatinEzetimibe and SimvastatinANI Pharmaceuticals, Inc.ANDACurrent
62559-702Ezetimibe and SimvastatinEzetimibe and SimvastatinANI Pharmaceuticals, Inc.ANDACurrent
62559-702Ezetimibe and SimvastatinEzetimibe and SimvastatinANI Pharmaceuticals, Inc.ANDACurrent
62559-702Ezetimibe and SimvastatinEzetimibe and SimvastatinANI Pharmaceuticals, Inc.ANDACurrent
62559-703Ezetimibe and SimvastatinEzetimibe and SimvastatinANI Pharmaceuticals, Inc.ANDACurrent
62559-703Ezetimibe and SimvastatinEzetimibe and SimvastatinANI Pharmaceuticals, Inc.ANDACurrent
62559-703Ezetimibe and SimvastatinEzetimibe and SimvastatinANI Pharmaceuticals, Inc.ANDACurrent
62559-703Ezetimibe and SimvastatinEzetimibe and SimvastatinANI Pharmaceuticals, Inc.ANDACurrent
62559-703Ezetimibe and SimvastatinEzetimibe and SimvastatinANI Pharmaceuticals, Inc.ANDACurrent
69238-1155Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals LLCANDACurrent
69238-1155Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1155Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1155Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1155Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1155Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals LLCANDACurrent
69238-1155Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1156Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals LLCANDACurrent
69238-1156Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1156Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1156Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1156Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1156Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals LLCANDACurrent
69238-1156Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1157Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals LLCANDACurrent
69238-1157Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1157Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1157Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1157Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1157Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1157Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals LLCANDACurrent
69238-1158Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals LLCANDACurrent
69238-1158Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1158Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1158Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1158Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1158Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals LLCANDACurrent
69238-1158Ezetimibe and SimvastatinEzetimibe and SimvastatinAmneal Pharmaceuticals NY LLCANDACurrent