FDA.reportPublic FDA data

Application 204991

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMTABLET;ORALEQ 10MG BASENoNo
002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMTABLET;ORALEQ 20MG BASENoNo
003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMTABLET;ORALEQ 40MG BASENoNo
004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMTABLET;ORALEQ 80MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-5632Atorvastatin CalciumAtorvastatin CalciumA-S Medication SolutionsANDACurrent
50090-5634Atorvastatin CalciumAtorvastatin CalciumA-S Medication SolutionsANDACurrent
50090-5636Atorvastatin CalciumAtorvastatin CalciumA-S Medication SolutionsANDACurrent
50090-5639Atorvastatin CalciumAtorvastatin CalciumA-S Medication SolutionsANDACurrent
68071-2439Atorvastatin CalciumAtorvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2452Atorvastatin CalciumAtorvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2465Atorvastatin CalciumAtorvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68180-635Atorvastatin CalciumAtorvastatin CalciumLupin Pharmaceuticals, Inc.ANDACurrent
68180-635Atorvastatin CalciumAtorvastatin CalciumLupin Pharmaceuticals, Inc.ANDACurrent
68180-635Atorvastatin CalciumAtorvastatin CalciumLupin Pharmaceuticals, Inc.ANDACurrent
68180-635Atorvastatin CalciumAtorvastatin CalciumLupin Pharmaceuticals, Inc.ANDACurrent
68180-635Atorvastatin CalciumAtorvastatin CalciumLupin Pharmaceuticals, Inc.ANDACurrent
68180-635Atorvastatin CalciumAtorvastatin CalciumLupin Pharmaceuticals, Inc.ANDACurrent
68180-636Atorvastatin CalciumAtorvastatin CalciumLupin Pharmaceuticals, Inc.ANDACurrent
68180-636Atorvastatin CalciumAtorvastatin CalciumLupin Pharmaceuticals, Inc.ANDACurrent
68180-636Atorvastatin CalciumAtorvastatin CalciumLupin Pharmaceuticals, Inc.ANDACurrent
68180-636Atorvastatin CalciumAtorvastatin CalciumLupin Pharmaceuticals, Inc.ANDACurrent
68180-636Atorvastatin CalciumAtorvastatin CalciumLupin Pharmaceuticals, Inc.ANDACurrent
68180-636Atorvastatin CalciumAtorvastatin CalciumLupin Pharmaceuticals, Inc.ANDACurrent
68180-637Atorvastatin CalciumAtorvastatin CalciumLupin Pharmaceuticals, Inc.ANDACurrent
68180-637Atorvastatin CalciumAtorvastatin CalciumLupin Pharmaceuticals, Inc.ANDACurrent
68180-637Atorvastatin CalciumAtorvastatin CalciumLupin Pharmaceuticals, Inc.ANDACurrent
68180-637Atorvastatin CalciumAtorvastatin CalciumLupin Pharmaceuticals, Inc.ANDACurrent
68180-637Atorvastatin CalciumAtorvastatin CalciumLupin Pharmaceuticals, Inc.ANDACurrent
68180-637Atorvastatin CalciumAtorvastatin CalciumLupin Pharmaceuticals, Inc.ANDACurrent
68180-638Atorvastatin CalciumAtorvastatin CalciumLupin Pharmaceuticals, Inc.ANDACurrent
68180-638Atorvastatin CalciumAtorvastatin CalciumLupin Pharmaceuticals, Inc.ANDACurrent
68180-638Atorvastatin CalciumAtorvastatin CalciumLupin Pharmaceuticals, Inc.ANDACurrent
68180-638Atorvastatin CalciumAtorvastatin CalciumLupin Pharmaceuticals, Inc.ANDACurrent
68180-638Atorvastatin CalciumAtorvastatin CalciumLupin Pharmaceuticals, Inc.ANDACurrent
68180-638Atorvastatin CalciumAtorvastatin CalciumLupin Pharmaceuticals, Inc.ANDACurrent
68788-7979Atorvastatin CalciumAtorvastatin CalciumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7979Atorvastatin CalciumAtorvastatin CalciumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-8132Atorvastatin CalciumAtorvastatin CalciumPreferred Pharmaceuticals, Inc.ANDACurrent
70518-3414Atorvastatin CalciumAtorvastatin CalciumREMEDYREPACK INC.ANDACurrent
71335-1929Atorvastatin CalciumAtorvastatin CalciumBryant Ranch PrepackANDACurrent
71335-1929Atorvastatin CalciumAtorvastatin CalciumBryant Ranch PrepackANDACurrent
72189-239ATORVASTATIN CALCIUMATORVASTATIN CALCIUMDIRECT RXANDACurrent
72189-239ATORVASTATIN CALCIUMATORVASTATIN CALCIUMDIRECT RXANDACurrent
72189-295ATORVASTATIN CALCIUMATORVASTATIN CALCIUMDirectRxANDACurrent