Amlodipine / atorvastatin Oral Tablet

Brand(s)
Caduet
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pfizer Labs (2015-04-14)
Oldest Current Product
2004-01-30
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\AMLODIPINE:ATORVASTATIN
FDAOB
ORAL\TABLET\AMLODIPINE BESYLATE: ATORVASTATIN CALCIUM
SPL Active
ORAL\TABLET, FILM COATED\AMLODIPINE BESYLATE: ATORVASTATIN CALCIUM TRIHYDRATE
SPL Moiety
ORAL\TABLET, FILM COATED\AMLODIPINE: ATORVASTATIN

product(s) by strength(s)

amlodipine 10 mg / atorvastatin 10 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000692160CaduetNDAPfizer Labs2004-01-30AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA0215406f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003784517ANDAMylan Pharmaceuticals Inc.2014-09-03AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDANDA2004654be76756-4114-4d50-a36c-fd410f6c773d
2003786168NDA AUTHORIZED GENERICMylan Pharmaceuticals Inc.2011-11-30AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA0215402f568859-64e6-454f-801b-c0a0a647dc3d
3435980321ANDADr. Reddy'S Laboratories Inc2014-03-17AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDANDA203874abee4a34-89cc-d886-192c-32582ab8f024
4597626730NDA AUTHORIZED GENERICGreenstone Llc2014-04-04AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA021540062bf1a0-9a29-4dee-a8cb-f0d051f4c0b1
5633040590NDA AUTHORIZED GENERICRnabaxy Pharmaceuticals Inc.2011-12-06AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA021540d2d28679-a01b-4e63-90e2-d5c23b393c94

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685567CaduetNDAPhysicians Total Care, Inc.2009-11-30AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATED000692160NDA021540909fad96-a941-443a-a39f-4f93607410fb

amlodipine 10 mg / atorvastatin 20 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000692180CaduetNDAPfizer Labs2004-01-30AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA0215406f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003784518ANDAMylan Pharmaceuticals Inc.2014-02-11AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDANDA2004654be76756-4114-4d50-a36c-fd410f6c773d
2003786169NDA AUTHORIZED GENERICMylan Pharmaceuticals Inc.2011-11-30AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA0215402f568859-64e6-454f-801b-c0a0a647dc3d
3435980318ANDADr. Reddy'S Laboratories Inc2014-03-17AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDANDA203874abee4a34-89cc-d886-192c-32582ab8f024
4597626731NDA AUTHORIZED GENERICGreenstone Llc2014-04-04AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA021540062bf1a0-9a29-4dee-a8cb-f0d051f4c0b1
5633040591NDA AUTHORIZED GENERICRnabaxy Pharmaceuticals Inc.2011-12-06AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA021540d2d28679-a01b-4e63-90e2-d5c23b393c94

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685209CaduetNDAPhysicians Total Care, Inc.2005-01-18AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATED000692180NDA021540909fad96-a941-443a-a39f-4f93607410fb

amlodipine 10 mg / atorvastatin 40 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000692250CaduetNDAPfizer Labs2004-01-30AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA0215406f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003784519ANDAMylan Pharmaceuticals Inc.2014-02-11AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDANDA2004654be76756-4114-4d50-a36c-fd410f6c773d
2003786170NDA AUTHORIZED GENERICMylan Pharmaceuticals Inc.2011-11-30AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA0215402f568859-64e6-454f-801b-c0a0a647dc3d
3435980315ANDADr. Reddy'S Laboratories Inc2014-03-17AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDANDA203874abee4a34-89cc-d886-192c-32582ab8f024
4597626732NDA AUTHORIZED GENERICGreenstone Llc2014-04-04AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA021540062bf1a0-9a29-4dee-a8cb-f0d051f4c0b1
5633040500NDA AUTHORIZED GENERICRnabaxy Pharmaceuticals Inc.2011-12-06AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA021540d2d28679-a01b-4e63-90e2-d5c23b393c94

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685200CaduetNDAPhysicians Total Care, Inc.2004-12-27AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATED000692250NDA021540909fad96-a941-443a-a39f-4f93607410fb

amlodipine 10 mg / atorvastatin 80 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000692270CaduetNDAPfizer Labs2004-01-30AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA0215406f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003784520ANDAMylan Pharmaceuticals Inc.2014-05-21AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDANDA2004654be76756-4114-4d50-a36c-fd410f6c773d
2003786171NDA AUTHORIZED GENERICMylan Pharmaceuticals Inc.2011-11-30AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA0215402f568859-64e6-454f-801b-c0a0a647dc3d
3435980313ANDADr. Reddy'S Laboratories Inc2014-03-17AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDANDA203874abee4a34-89cc-d886-192c-32582ab8f024
4597626733NDA AUTHORIZED GENERICGreenstone Llc2014-04-04AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA021540062bf1a0-9a29-4dee-a8cb-f0d051f4c0b1
5633040603NDA AUTHORIZED GENERICRnabaxy Pharmaceuticals Inc.2011-12-06AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA021540d2d28679-a01b-4e63-90e2-d5c23b393c94

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685523CaduetNDAPhysicians Total Care, Inc.2009-04-15AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATED000692270NDA021540909fad96-a941-443a-a39f-4f93607410fb
2548686335NDA AUTHORIZED GENERICPhysicians Total Care, Inc.2012-03-08AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATED633040603NDA02154011b56661-6657-4a83-93a3-7cb481d946f7

amlodipine 2.5 mg / atorvastatin 10 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000692960CaduetNDAPfizer Labs2004-01-30AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA0215406f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003784510ANDAMylan Pharmaceuticals Inc.2014-06-24AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDANDA2004654be76756-4114-4d50-a36c-fd410f6c773d
2003786161NDA AUTHORIZED GENERICMylan Pharmaceuticals Inc.2011-11-30AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA0215402f568859-64e6-454f-801b-c0a0a647dc3d
3435980323ANDADr. Reddy'S Laboratories Inc2014-03-17AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDANDA203874abee4a34-89cc-d886-192c-32582ab8f024
4597626710NDA AUTHORIZED GENERICGreenstone Llc2014-04-04AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA021540062bf1a0-9a29-4dee-a8cb-f0d051f4c0b1
5633040501NDA AUTHORIZED GENERICRnabaxy Pharmaceuticals Inc.2011-12-06AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA021540d2d28679-a01b-4e63-90e2-d5c23b393c94

amlodipine 2.5 mg / atorvastatin 20 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000692970CaduetNDAPfizer Labs2004-01-30AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA0215406f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003784511ANDAMylan Pharmaceuticals Inc.2014-06-19AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDANDA2004654be76756-4114-4d50-a36c-fd410f6c773d
2003786162NDA AUTHORIZED GENERICMylan Pharmaceuticals Inc.2011-11-30AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA0215402f568859-64e6-454f-801b-c0a0a647dc3d
3435980320ANDADr. Reddy'S Laboratories Inc2014-03-17AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDANDA203874abee4a34-89cc-d886-192c-32582ab8f024
4597626711NDA AUTHORIZED GENERICGreenstone Llc2014-04-04AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA021540062bf1a0-9a29-4dee-a8cb-f0d051f4c0b1
5633040502NDA AUTHORIZED GENERICRnabaxy Pharmaceuticals Inc.2011-12-06AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA021540d2d28679-a01b-4e63-90e2-d5c23b393c94

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685672CaduetNDAPhysicians Total Care, Inc.2006-09-21AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATED000692970NDA021540909fad96-a941-443a-a39f-4f93607410fb

amlodipine 2.5 mg / atorvastatin 40 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000692980CaduetNDAPfizer Labs2004-01-30AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA0215406f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003784512ANDAMylan Pharmaceuticals Inc.2014-02-11AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDANDA2004654be76756-4114-4d50-a36c-fd410f6c773d
2003786163NDA AUTHORIZED GENERICMylan Pharmaceuticals Inc.2011-11-30AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA0215402f568859-64e6-454f-801b-c0a0a647dc3d
3435980317ANDADr. Reddy'S Laboratories Inc2014-03-17AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDANDA203874abee4a34-89cc-d886-192c-32582ab8f024
4597626712NDA AUTHORIZED GENERICGreenstone Llc2014-04-04AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA021540062bf1a0-9a29-4dee-a8cb-f0d051f4c0b1
5633040503NDA AUTHORIZED GENERICRnabaxy Pharmaceuticals Inc.2011-12-06AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA021540d2d28679-a01b-4e63-90e2-d5c23b393c94

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685699CaduetNDAPhysicians Total Care, Inc.2006-11-02AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATED000692980NDA021540909fad96-a941-443a-a39f-4f93607410fb

amlodipine 5 mg / atorvastatin 10 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000692150CaduetNDAPfizer Labs2004-01-30AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA0215406f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003784513ANDAMylan Pharmaceuticals Inc.2014-02-11AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDANDA2004654be76756-4114-4d50-a36c-fd410f6c773d
2003786164NDA AUTHORIZED GENERICMylan Pharmaceuticals Inc.2011-11-30AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA0215402f568859-64e6-454f-801b-c0a0a647dc3d
3435980322ANDADr. Reddy'S Laboratories Inc2014-03-17AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDANDA203874abee4a34-89cc-d886-192c-32582ab8f024
4597626720NDA AUTHORIZED GENERICGreenstone Llc2014-04-04AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA021540062bf1a0-9a29-4dee-a8cb-f0d051f4c0b1
5633040587NDA AUTHORIZED GENERICRnabaxy Pharmaceuticals Inc.2011-12-06AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA021540d2d28679-a01b-4e63-90e2-d5c23b393c94

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548683287CaduetNDAPhysicians Total Care, Inc.2009-04-15AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATED000692150NDA021540909fad96-a941-443a-a39f-4f93607410fb

amlodipine 5 mg / atorvastatin 20 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000692170CaduetNDAPfizer Labs2004-01-30AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA0215406f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003784514ANDAMylan Pharmaceuticals Inc.2014-05-21AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDANDA2004654be76756-4114-4d50-a36c-fd410f6c773d
2003786165NDA AUTHORIZED GENERICMylan Pharmaceuticals Inc.2011-11-30AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA0215402f568859-64e6-454f-801b-c0a0a647dc3d
3435980319ANDADr. Reddy'S Laboratories Inc2014-03-17AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDANDA203874abee4a34-89cc-d886-192c-32582ab8f024
4597626721NDA AUTHORIZED GENERICGreenstone Llc2014-04-04AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA021540062bf1a0-9a29-4dee-a8cb-f0d051f4c0b1
5633040588NDA AUTHORIZED GENERICRnabaxy Pharmaceuticals Inc.2011-12-06AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA021540d2d28679-a01b-4e63-90e2-d5c23b393c94

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548681207CaduetNDAPhysicians Total Care, Inc.2005-01-12AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATED000692170NDA021540909fad96-a941-443a-a39f-4f93607410fb

amlodipine 5 mg / atorvastatin 40 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000692190CaduetNDAPfizer Labs2004-01-30AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA0215406f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003784515ANDAMylan Pharmaceuticals Inc.2014-06-24AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDANDA2004654be76756-4114-4d50-a36c-fd410f6c773d
2003786166NDA AUTHORIZED GENERICMylan Pharmaceuticals Inc.2011-11-30AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA0215402f568859-64e6-454f-801b-c0a0a647dc3d
3435980316ANDADr. Reddy'S Laboratories Inc2014-03-17AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDANDA203874abee4a34-89cc-d886-192c-32582ab8f024
4597626722NDA AUTHORIZED GENERICGreenstone Llc2014-04-04AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA021540062bf1a0-9a29-4dee-a8cb-f0d051f4c0b1
5633040589NDA AUTHORIZED GENERICRnabaxy Pharmaceuticals Inc.2004-01-30AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA021540d2d28679-a01b-4e63-90e2-d5c23b393c94

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685179CaduetNDAPhysicians Total Care, Inc.2004-11-11AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATED000692190NDA021540909fad96-a941-443a-a39f-4f93607410fb

amlodipine 5 mg / atorvastatin 80 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000692260CaduetNDAPfizer Labs2004-01-30AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA0215406f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003784516ANDAMylan Pharmaceuticals Inc.2014-10-10AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDANDA2004654be76756-4114-4d50-a36c-fd410f6c773d
2003786167NDA AUTHORIZED GENERICMylan Pharmaceuticals Inc.2011-11-30AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA0215402f568859-64e6-454f-801b-c0a0a647dc3d
3435980314ANDADr. Reddy'S Laboratories Inc2014-03-17AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDANDA203874abee4a34-89cc-d886-192c-32582ab8f024
4597626723NDA AUTHORIZED GENERICGreenstone Llc2014-04-04AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA021540062bf1a0-9a29-4dee-a8cb-f0d051f4c0b1
5633040499NDA AUTHORIZED GENERICRnabaxy Pharmaceuticals Inc.2011-12-06AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATEDNDA021540d2d28679-a01b-4e63-90e2-d5c23b393c94

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685420CaduetNDAPhysicians Total Care, Inc.2005-09-14AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATEORALTABLET, FILM COATED000692260NDA021540909fad96-a941-443a-a39f-4f93607410fb

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA200465AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMMYLAN PHARMACEUTICALS INC2013-11-29ANDA200465_001, ANDA200465_002, ANDA200465_003, ANDA200465_004, ANDA200465_005, ANDA200465_006, ANDA200465_007, ANDA200465_008, ANDA200465_009, ANDA200465_010, ANDA200465_011
2ANDA203874AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMDR REDDYS LABORATORIES LTD2014-03-07ANDA203874_001, ANDA203874_002, ANDA203874_003, ANDA203874_004, ANDA203874_005, ANDA203874_006, ANDA203874_007, ANDA203874_008, ANDA203874_009, ANDA203874_010, ANDA203874_011
3NDA021540CADUETPFIZER INC2004-01-30p6455574, TREATMENT OF HYPERTENSION AND HYPERLIPIDEMIA WITH A SINGLE COMPOSITION
p5969156
p5686104, METHOD OF INHIBITING CHOLESTEROL BIOSYNTHESIS AND TREATING HYPERCHOLESTEROLEMIA AND METHOD FOR TREATING HYPERLIPIDEMIA, SUBSTANCE
NDA021540_001, NDA021540_002, NDA021540_003, NDA021540_004, NDA021540_005, NDA021540_006, NDA021540_007, NDA021540_008, NDA021540_009, NDA021540_010, NDA021540_011

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA200465_001RXATORVASTATIN CALCIUM (EQ 10MG BASE), AMLODIPINE BESYLATE (EQ 2.5MG BASE)ORALTABLETFalseAB2013-11-29AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
2ANDA200465_002RXAMLODIPINE BESYLATE (EQ 2.5MG BASE), ATORVASTATIN CALCIUM (EQ 20MG BASE)ORALTABLETFalseAB2013-11-29AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
3ANDA200465_003RXATORVASTATIN CALCIUM (EQ 40MG BASE), AMLODIPINE BESYLATE (EQ 2.5MG BASE)ORALTABLETFalseAB2013-11-29AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
4ANDA200465_004RXATORVASTATIN CALCIUM (EQ 10MG BASE), AMLODIPINE BESYLATE (EQ 5MG BASE)ORALTABLETFalseAB2013-11-29AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
5ANDA200465_005RXAMLODIPINE BESYLATE (EQ 5MG BASE), ATORVASTATIN CALCIUM (EQ 20MG BASE)ORALTABLETFalseAB2013-11-29AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
6ANDA200465_006RXATORVASTATIN CALCIUM (EQ 40MG BASE), AMLODIPINE BESYLATE (EQ 5MG BASE)ORALTABLETFalseAB2013-11-29AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
7ANDA200465_007RXATORVASTATIN CALCIUM (EQ 80MG BASE), AMLODIPINE BESYLATE (EQ 5MG BASE)ORALTABLETFalseAB2013-11-29AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
8ANDA200465_008RXATORVASTATIN CALCIUM (EQ 10MG BASE), AMLODIPINE BESYLATE (EQ 10MG BASE)ORALTABLETFalseAB2013-11-29AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
9ANDA200465_009RXAMLODIPINE BESYLATE (EQ 10MG BASE), ATORVASTATIN CALCIUM (EQ 20MG BASE)ORALTABLETFalseAB2013-11-29AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
10ANDA200465_010RXATORVASTATIN CALCIUM (EQ 40MG BASE), AMLODIPINE BESYLATE (EQ 10MG BASE)ORALTABLETFalseAB2013-11-29AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
11ANDA200465_011RXAMLODIPINE BESYLATE (EQ 10MG BASE), ATORVASTATIN CALCIUM (EQ 80MG BASE)ORALTABLETFalseAB2013-11-29AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
12ANDA203874_001RXATORVASTATIN CALCIUM (EQ 10MG BASE), AMLODIPINE BESYLATE (EQ 2.5MG BASE)ORALTABLETFalseAB2014-03-07AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
13ANDA203874_002RXATORVASTATIN CALCIUM (EQ 20MG BASE), AMLODIPINE BESYLATE (EQ 2.5MG BASE)ORALTABLETFalseAB2014-03-07AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
14ANDA203874_003RXATORVASTATIN CALCIUM (EQ 40MG BASE), AMLODIPINE BESYLATE (EQ 2.5MG BASE)ORALTABLETFalseAB2014-03-07AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
15ANDA203874_004RXAMLODIPINE BESYLATE (EQ 5MG BASE), ATORVASTATIN CALCIUM (EQ 10MG BASE)ORALTABLETFalseAB2014-03-07AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
16ANDA203874_005RXAMLODIPINE BESYLATE (EQ 5MG BASE), ATORVASTATIN CALCIUM (EQ 20MG BASE)ORALTABLETFalseAB2014-03-07AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
17ANDA203874_006RXATORVASTATIN CALCIUM (EQ 40MG BASE), AMLODIPINE BESYLATE (EQ 5MG BASE)ORALTABLETFalseAB2014-03-07AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
18ANDA203874_007RXATORVASTATIN CALCIUM (EQ 80MG BASE), AMLODIPINE BESYLATE (EQ 5MG BASE)ORALTABLETFalseAB2014-03-07AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
19ANDA203874_008RXAMLODIPINE BESYLATE (EQ 10MG BASE), ATORVASTATIN CALCIUM (EQ 10MG BASE)ORALTABLETFalseAB2014-03-07AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
20ANDA203874_009RXATORVASTATIN CALCIUM (EQ 20MG BASE), AMLODIPINE BESYLATE (EQ 10MG BASE)ORALTABLETFalseAB2014-03-07AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
21ANDA203874_010RXAMLODIPINE BESYLATE (EQ 10MG BASE), ATORVASTATIN CALCIUM (EQ 40MG BASE)ORALTABLETFalseAB2014-03-07AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
22ANDA203874_011RXAMLODIPINE BESYLATE (EQ 10MG BASE), ATORVASTATIN CALCIUM (EQ 80MG BASE)ORALTABLETFalseAB2014-03-07AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
23NDA021540_001RXATORVASTATIN CALCIUM (EQ 10MG BASE), AMLODIPINE BESYLATE (EQ 5MG BASE)ORALTABLETFalseAB2004-01-30CADUET
24NDA021540_002RXATORVASTATIN CALCIUM (EQ 20MG BASE), AMLODIPINE BESYLATE (EQ 5MG BASE)ORALTABLETFalseAB2004-01-30CADUET
25NDA021540_003RXATORVASTATIN CALCIUM (EQ 40MG BASE), AMLODIPINE BESYLATE (EQ 5MG BASE)ORALTABLETFalseAB2004-01-30CADUET
26NDA021540_004RXAMLODIPINE BESYLATE (EQ 5MG BASE), ATORVASTATIN CALCIUM (EQ 80MG BASE)ORALTABLETFalseAB2004-01-30CADUET
27NDA021540_005RXATORVASTATIN CALCIUM (EQ 10MG BASE), AMLODIPINE BESYLATE (EQ 10MG BASE)ORALTABLETFalseAB2004-01-30CADUET
28NDA021540_006RXATORVASTATIN CALCIUM (EQ 20MG BASE), AMLODIPINE BESYLATE (EQ 10MG BASE)ORALTABLETFalseAB2004-01-30CADUET
29NDA021540_007RXATORVASTATIN CALCIUM (EQ 40MG BASE), AMLODIPINE BESYLATE (EQ 10MG BASE)ORALTABLETFalseAB2004-01-30CADUET
30NDA021540_008RXATORVASTATIN CALCIUM (EQ 80MG BASE), AMLODIPINE BESYLATE (EQ 10MG BASE)ORALTABLETTrueAB2004-01-30CADUET
31NDA021540_009RXAMLODIPINE BESYLATE (EQ 2.5MG BASE), ATORVASTATIN CALCIUM (EQ 10MG BASE)ORALTABLETFalseAB2004-07-29CADUET
32NDA021540_010RXAMLODIPINE BESYLATE (EQ 2.5MG BASE), ATORVASTATIN CALCIUM (EQ 20MG BASE)ORALTABLETFalseAB2004-07-29CADUET
33NDA021540_011RXATORVASTATIN CALCIUM (EQ 40MG BASE), AMLODIPINE BESYLATE (EQ 2.5MG BASE)ORALTABLETFalseAB2004-07-29CADUET

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5686104 (view patent)2014-11-11NDA021540, NDA020702, NDA200153atorvastatin / ezetimibe Oral Tablet
atorvastatin Oral Tablet
2p5969156 (view patent)2016-07-08NDA021540, NDA020702, NDA200153atorvastatin / ezetimibe Oral Tablet
atorvastatin Oral Tablet
3p6455574 (view patent)2018-08-11NDA021540

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1062bf1a0-9a29-4dee-a8cb-f0d051f4c0b1 (view SPL)These highlights do not include all the information needed to use Amlodipine besylate and atorvastatin calcium tablets safely and effectively. See full prescribing information for amlodipine besylate and atorvastatin calcium tablets. Amlodipine besylate and atorvastatin calcium tablets, for oral use Initial U.S. Approval: 2004prescriptionHuman PrescriptionGreenstone LlcANALYSIS, API MANUFACTURE, MANUFACTURE, PACK, REPACK2015-04-2810597626710, 597626711, 597626712, 597626720, 597626721, 597626722, 597626723, 597626730, 597626731, 597626732, 597626733
211b56661-6657-4a83-93a3-7cb481d946f7 (view SPL)AMLODIPINE BESYLATE/ATORVASTATIN CALCIUM TABLETSprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-06-273548686335
32f568859-64e6-454f-801b-c0a0a647dc3d (view SPL)These highlights do not include all the information needed to use Amlodipine besylate and atorvastatin calcium tablets safely and effectively. See full prescribing information for Amlodipine besylate and atorvastatin calcium tablets. Amlodipine besylate and atorvastatin calcium tablets, for oral useInitial U.S. Approval: 2004prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.API MANUFACTURE, MANUFACTURE, PACK, REPACK2014-05-098003786161, 003786162, 003786163, 003786164, 003786165, 003786166, 003786167, 003786168, 003786169, 003786170, 003786171
44be76756-4114-4d50-a36c-fd410f6c773d (view SPL)These highlights do not include all the information needed to use AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLETS. AMLODIPINE BESYLATE and ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 2004prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-05-154003784510, 003784511, 003784512, 003784513, 003784514, 003784515, 003784516, 003784517, 003784518, 003784519, 003784520
56f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 (view SPL)These highlights do not include all the information needed to use CADUET safely and effectively. See full prescribing information for CADUET. CADUET (amlodipine besylate and atorvastatin calcium) tablets, for oral use Initial U.S. Approval: 2004prescriptionHuman PrescriptionPfizer LabsANALYSIS, API MANUFACTURE, MANUFACTURE, PACK, REPACK2015-04-1423000692150, 000692160, 000692170, 000692180, 000692190, 000692250, 000692260, 000692270, 000692960, 000692970, 000692980
6909fad96-a941-443a-a39f-4f93607410fb (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2009-11-301548681207, 548683287, 548685179, 548685200, 548685209, 548685420, 548685523, 548685567, 548685672, 548685699
7abee4a34-89cc-d886-192c-32582ab8f024 (view SPL)These highlights do not include all the information needed to use amlodipine besylate and atorvastatin calcium safely and effectively. See full prescribing information for amlodipine besylate and atorvastatin calcium. AMLODIPINE besylate and ATORVASTATIN calcium tablets, for oral use Initial U.S. Approval: 2004prescriptionHuman PrescriptionDr. Reddy'S Laboratories Incanalysis, manufacture2015-04-307435980313, 435980314, 435980315, 435980316, 435980317, 435980318, 435980319, 435980320, 435980321, 435980322, 435980323
8d2d28679-a01b-4e63-90e2-d5c23b393c94 (view SPL)These highlights do not include all the information needed to use AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLETS. AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLETS, for oral use Initial U.S. Approval: 2004prescriptionHuman PrescriptionRnabaxy Pharmaceuticals Inc.API MANUFACTURE, MANUFACTURE, PACK, REPACK2014-03-047633040499, 633040500, 633040501, 633040502, 633040503, 633040587, 633040588, 633040589, 633040590, 633040591, 633040603

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII