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Abbreviated New Drug Application (ANDA): 200465
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 10MG BASE TABLET;ORAL Discontinued None No No
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 20MG BASE TABLET;ORAL Discontinued None No No
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 40MG BASE TABLET;ORAL Discontinued None No No
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 10MG BASE TABLET;ORAL Prescription AB No No
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 20MG BASE TABLET;ORAL Prescription AB No No
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 40MG BASE TABLET;ORAL Prescription AB No No
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 80MG BASE TABLET;ORAL Prescription AB No No
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 10MG BASE TABLET;ORAL Prescription AB No No
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 20MG BASE TABLET;ORAL Prescription AB No No
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 40MG BASE TABLET;ORAL Prescription AB No No
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 80MG BASE TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/29/2013 ORIG-1 Approval Not Applicable Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200465Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/06/2019 SUPPL-6 Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

11/16/2015 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM

TABLET;ORAL; EQ 5MG BASE;EQ 10MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 10MG BASE TABLET;ORAL Prescription No AB 205199 APOTEX
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 10MG BASE TABLET;ORAL Prescription No AB 203874 DR REDDYS
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 10MG BASE TABLET;ORAL Prescription No AB 200465 MYLAN
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 10MG BASE TABLET;ORAL Prescription No AB 207762 ZYDUS PHARMS
CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 10MG BASE TABLET;ORAL Prescription Yes AB 021540 PHARMACIA

TABLET;ORAL; EQ 5MG BASE;EQ 20MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 20MG BASE TABLET;ORAL Prescription No AB 205199 APOTEX
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 20MG BASE TABLET;ORAL Prescription No AB 203874 DR REDDYS
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 20MG BASE TABLET;ORAL Prescription No AB 200465 MYLAN
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 20MG BASE TABLET;ORAL Prescription No AB 207762 ZYDUS PHARMS
CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 20MG BASE TABLET;ORAL Prescription Yes AB 021540 PHARMACIA

TABLET;ORAL; EQ 5MG BASE;EQ 40MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 40MG BASE TABLET;ORAL Prescription No AB 205199 APOTEX
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 40MG BASE TABLET;ORAL Prescription No AB 203874 DR REDDYS
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 40MG BASE TABLET;ORAL Prescription No AB 200465 MYLAN
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 40MG BASE TABLET;ORAL Prescription No AB 207762 ZYDUS PHARMS
CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 40MG BASE TABLET;ORAL Prescription Yes AB 021540 PHARMACIA

TABLET;ORAL; EQ 5MG BASE;EQ 80MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 80MG BASE TABLET;ORAL Prescription No AB 205199 APOTEX
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 80MG BASE TABLET;ORAL Prescription No AB 203874 DR REDDYS
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 80MG BASE TABLET;ORAL Prescription No AB 200465 MYLAN
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 80MG BASE TABLET;ORAL Prescription No AB 207762 ZYDUS PHARMS
CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 80MG BASE TABLET;ORAL Prescription Yes AB 021540 PHARMACIA

TABLET;ORAL; EQ 10MG BASE;EQ 10MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 10MG BASE TABLET;ORAL Prescription No AB 205199 APOTEX
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 10MG BASE TABLET;ORAL Prescription No AB 203874 DR REDDYS
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 10MG BASE TABLET;ORAL Prescription No AB 200465 MYLAN
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 10MG BASE TABLET;ORAL Prescription No AB 207762 ZYDUS PHARMS
CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 10MG BASE TABLET;ORAL Prescription Yes AB 021540 PHARMACIA

TABLET;ORAL; EQ 10MG BASE;EQ 20MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 20MG BASE TABLET;ORAL Prescription No AB 205199 APOTEX
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 20MG BASE TABLET;ORAL Prescription No AB 203874 DR REDDYS
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 20MG BASE TABLET;ORAL Prescription No AB 200465 MYLAN
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 20MG BASE TABLET;ORAL Prescription No AB 207762 ZYDUS PHARMS
CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 20MG BASE TABLET;ORAL Prescription Yes AB 021540 PHARMACIA

TABLET;ORAL; EQ 10MG BASE;EQ 40MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 40MG BASE TABLET;ORAL Prescription No AB 205199 APOTEX
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 40MG BASE TABLET;ORAL Prescription No AB 203874 DR REDDYS
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 40MG BASE TABLET;ORAL Prescription No AB 200465 MYLAN
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 40MG BASE TABLET;ORAL Prescription No AB 207762 ZYDUS PHARMS
CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 40MG BASE TABLET;ORAL Prescription Yes AB 021540 PHARMACIA

TABLET;ORAL; EQ 10MG BASE;EQ 80MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 80MG BASE TABLET;ORAL Prescription No AB 205199 APOTEX
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 80MG BASE TABLET;ORAL Prescription No AB 203874 DR REDDYS
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 80MG BASE TABLET;ORAL Prescription No AB 200465 MYLAN
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 80MG BASE TABLET;ORAL Prescription No AB 207762 ZYDUS PHARMS
CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 80MG BASE TABLET;ORAL Prescription Yes AB 021540 PHARMACIA
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