Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076719
Company: APOTEX
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
05/23/2007 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
09/25/2015 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

08/26/2013 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

08/26/2013 SUPPL-8 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert

Label is not available on this site.

03/22/2011 SUPPL-6 Labeling-Package Insert

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 078477 AMNEAL PHARMS NY
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 090752 CHINA RESOURCES
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 077073 CIPLA LTD
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 076692 DR REDDYS LABS LTD
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 077771 HIKMA PHARMS
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 076418 MYLAN PHARMS INC
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 078453 ORCHID HLTHCARE
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 078231 SUN PHARM INDS INC
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 078573 TORRENT PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 203245 UNICHEM LABS LTD
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 077759 UPSHER-SMITH LABS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 078414 VINTAGE
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 077516 VIVIMED GLOBAL
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 077671 WATSON LABS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 077262 WEST-WARD PHARMS INT
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 078500 WOCKHARDT
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 PFIZER

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 078477 AMNEAL PHARMS NY
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 090752 CHINA RESOURCES
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 077073 CIPLA LTD
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 076692 DR REDDYS LABS LTD
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 077771 HIKMA PHARMS
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 201380 MACLEODS PHARMS LTD
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 076418 MYLAN PHARMS INC
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 078453 ORCHID HLTHCARE
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 078231 SUN PHARM INDS INC
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 078573 TORRENT PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 203245 UNICHEM LABS LTD
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 077759 UPSHER-SMITH LABS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 078414 VINTAGE
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 077516 VIVIMED GLOBAL
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 077671 WATSON LABS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 077262 WEST-WARD PHARMS INT
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 078500 WOCKHARDT
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 PFIZER

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 078477 AMNEAL PHARMS NY
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 090752 CHINA RESOURCES
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 077073 CIPLA LTD
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 076692 DR REDDYS LABS LTD
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 077771 HIKMA PHARMS
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 201380 MACLEODS PHARMS LTD
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 076418 MYLAN PHARMS INC
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 078453 ORCHID HLTHCARE
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 078231 SUN PHARM INDS INC
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 078573 TORRENT PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 203245 UNICHEM LABS LTD
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 077759 UPSHER-SMITH LABS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 078414 VINTAGE
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 077516 VIVIMED GLOBAL
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 077671 WATSON LABS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 077262 WEST-WARD PHARMS INT
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 078500 WOCKHARDT
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 PFIZER

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