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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076846
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription AB No No
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription AB No No
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG 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
06/28/2007 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/14/2018 SUPPL-16 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

10/01/2015 SUPPL-14 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

05/02/2013 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

08/30/2013 SUPPL-12 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

12/31/2011 SUPPL-10 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

07/27/2011 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

04/09/2010 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

03/12/2009 SUPPL-6 Labeling

Label is not available on this site.

04/14/2008 SUPPL-4 Labeling

Label is not available on this site.

08/30/2007 SUPPL-1 Labeling

Label is not available on this site.

AMLODIPINE BESYLATE

TABLET;ORAL; EQ 2.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 202553 ACCORD HLTHCARE
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 078925 ALKEM
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 076719 APOTEX
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 078021 AUROBINDO PHARMA
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 076692 CHARTWELL RX
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 090752 CHINA RESOURCES
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 077073 CIPLA
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 078552 EPIC PHARMA LLC
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 077955 INVAGEN PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 206367 INVAGEN PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 078043 LUPIN
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 078453 ORBION PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 078414 OXFORD PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 207821 POLYGEN PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 077516 STRIDES PHARMA
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 077974 SUN PHARM INDS LTD
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 076846 TEVA
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 203245 UNICHEM
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 078226 ZYDUS PHARMS USA
NORVASC AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription Yes AB 019787 VIATRIS

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 202553 ACCORD HLTHCARE
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 078925 ALKEM
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 076719 APOTEX
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 078021 AUROBINDO PHARMA
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 076692 CHARTWELL RX
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 090752 CHINA RESOURCES
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 077073 CIPLA
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 078552 EPIC PHARMA LLC
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 077955 INVAGEN PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 206367 INVAGEN PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 078043 LUPIN
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 078453 ORBION PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 078414 OXFORD PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 207821 POLYGEN PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 077516 STRIDES PHARMA
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 077974 SUN PHARM INDS LTD
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 076846 TEVA
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 203245 UNICHEM
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 078226 ZYDUS PHARMS USA
NORVASC AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription Yes AB 019787 VIATRIS

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 202553 ACCORD HLTHCARE
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 078925 ALKEM
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 076719 APOTEX
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 078021 AUROBINDO PHARMA
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 076692 CHARTWELL RX
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 090752 CHINA RESOURCES
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 077073 CIPLA
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 078552 EPIC PHARMA LLC
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 077955 INVAGEN PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 206367 INVAGEN PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 078043 LUPIN
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 078453 ORBION PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 078414 OXFORD PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 207821 POLYGEN PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 077516 STRIDES PHARMA
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 077974 SUN PHARM INDS LTD
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 076846 TEVA
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 203245 UNICHEM
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 078226 ZYDUS PHARMS USA
NORVASC AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription Yes AB 019787 VIATRIS
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