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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090364
Company: WATSON LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE;ORAL Prescription AB No No
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE;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
07/05/2011 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
04/17/2020 SUPPL-12 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

04/17/2020 SUPPL-11 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

04/17/2020 SUPPL-10 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

11/05/2014 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

09/27/2012 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

08/19/2011 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE;ORAL Prescription No AB 091431 APOTEX
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE;ORAL Prescription No AB 202239 AUROBINDO PHARMA LTD
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE;ORAL Prescription No AB 090149 DR REDDYS LABS INC
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE;ORAL Prescription No AB 078466 LUPIN PHARMS
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE;ORAL Prescription No AB 090364 WATSON LABS INC
LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE;ORAL Prescription Yes AB 020364 NOVARTIS

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE;ORAL Prescription No AB 091431 APOTEX
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE;ORAL Prescription No AB 202239 AUROBINDO PHARMA LTD
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE;ORAL Prescription No AB 090149 DR REDDYS LABS INC
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE;ORAL Prescription No AB 078466 LUPIN PHARMS
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE;ORAL Prescription No AB 090364 WATSON LABS INC
LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE;ORAL Prescription Yes AB 020364 NOVARTIS
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