FDA.reportPublic FDA data

Application 205199

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMTABLET;ORALEQ 5MG BASE;EQ 10MG BASENoNo
002AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMTABLET;ORALEQ 5MG BASE;EQ 20MG BASENoNo
003AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMTABLET;ORALEQ 5MG BASE;EQ 40MG BASENoNo
004AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMTABLET;ORALEQ 5MG BASE;EQ 80MG BASENoNo
005AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMTABLET;ORALEQ 10MG BASE;EQ 10MG BASENoNo
006AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMTABLET;ORALEQ 10MG BASE;EQ 20MG BASENoNo
007AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMTABLET;ORALEQ 10MG BASE;EQ 40MG BASENoNo
008AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMTABLET;ORALEQ 10MG BASE;EQ 80MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-3478Amlodipine and AtorvastatinAmlodipine and AtorvastatinApotex Corp.ANDACurrent
60505-3478Amlodipine and AtorvastatinAmlodipine and AtorvastatinApotex Corp.ANDACurrent
60505-3478Amlodipine and AtorvastatinAmlodipine and AtorvastatinApotex Corp.ANDACurrent
60505-3479Amlodipine and AtorvastatinAmlodipine and AtorvastatinApotex Corp.ANDACurrent
60505-3479Amlodipine and AtorvastatinAmlodipine and AtorvastatinApotex Corp.ANDACurrent
60505-3479Amlodipine and AtorvastatinAmlodipine and AtorvastatinApotex Corp.ANDACurrent
60505-3483Amlodipine and AtorvastatinAmlodipine and AtorvastatinApotex Corp.ANDACurrent
60505-3483Amlodipine and AtorvastatinAmlodipine and AtorvastatinApotex Corp.ANDACurrent
60505-3483Amlodipine and AtorvastatinAmlodipine and AtorvastatinApotex Corp.ANDACurrent
60505-3484Amlodipine and AtorvastatinAmlodipine and AtorvastatinApotex Corp.ANDACurrent
60505-3484Amlodipine and AtorvastatinAmlodipine and AtorvastatinApotex Corp.ANDACurrent
60505-3484Amlodipine and AtorvastatinAmlodipine and AtorvastatinApotex Corp.ANDACurrent
60505-3488Amlodipine and AtorvastatinAmlodipine and AtorvastatinApotex Corp.ANDACurrent
60505-3488Amlodipine and AtorvastatinAmlodipine and AtorvastatinApotex Corp.ANDACurrent
60505-3488Amlodipine and AtorvastatinAmlodipine and AtorvastatinApotex Corp.ANDACurrent
60505-3489Amlodipine and AtorvastatinAmlodipine and AtorvastatinApotex Corp.ANDACurrent
60505-3489Amlodipine and AtorvastatinAmlodipine and AtorvastatinApotex Corp.ANDACurrent
60505-3489Amlodipine and AtorvastatinAmlodipine and AtorvastatinApotex Corp.ANDACurrent
60505-3492Amlodipine and AtorvastatinAmlodipine and AtorvastatinApotex Corp.ANDACurrent
60505-3492Amlodipine and AtorvastatinAmlodipine and AtorvastatinApotex Corp.ANDACurrent
60505-3492Amlodipine and AtorvastatinAmlodipine and AtorvastatinApotex Corp.ANDACurrent
60505-3493Amlodipine and AtorvastatinAmlodipine and AtorvastatinApotex Corp.ANDACurrent
60505-3493Amlodipine and AtorvastatinAmlodipine and AtorvastatinApotex Corp.ANDACurrent
60505-3493Amlodipine and AtorvastatinAmlodipine and AtorvastatinApotex Corp.ANDACurrent