U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077183
Company: DR REDDYS 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 2.5MG BASE;10MG CAPSULE;ORAL Prescription AB No No
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE;ORAL Prescription AB No No
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE;ORAL Prescription AB No No
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG 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
04/15/2010 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
11/22/2019 SUPPL-13 Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.
01/04/2016 SUPPL-12 Labeling-Package Insert

Label is not available on this site.
01/04/2016 SUPPL-11 Labeling-Package Insert

Label is not available on this site.
10/26/2014 SUPPL-6 Labeling-Package Insert

Label is not available on this site.
02/23/2012 SUPPL-5 Labeling-Package Insert

Label is not available on this site.
12/12/2011 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
10/27/2011 SUPPL-3 Labeling-Package Insert

Label is not available on this site.
02/14/2011 SUPPL-2 Labeling-Package Insert

Label is not available on this site.
06/04/2010 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

CAPSULE;ORAL; EQ 2.5MG BASE;10MG
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 2.5MG BASE;10MG CAPSULE;ORAL Prescription No AB 202239 AUROBINDO PHARMA LTD
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE;ORAL Prescription No AB 077183 DR REDDYS LABS INC
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE;ORAL Prescription No AB 091431 HERITAGE
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE;ORAL Prescription No AB 078466 LUPIN PHARMS
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE;ORAL Prescription No AB 077890 WATSON LABS

CAPSULE;ORAL; EQ 5MG BASE;10MG
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;10MG CAPSULE;ORAL Prescription No AB 202239 AUROBINDO PHARMA LTD
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE;ORAL Prescription No AB 077183 DR REDDYS LABS INC
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE;ORAL Prescription No AB 091431 HERITAGE
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE;ORAL Prescription No AB 078466 LUPIN PHARMS
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE;ORAL Prescription No AB 077890 WATSON LABS

CAPSULE;ORAL; EQ 5MG BASE;20MG
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;20MG CAPSULE;ORAL Prescription No AB 202239 AUROBINDO PHARMA LTD
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE;ORAL Prescription No AB 077183 DR REDDYS LABS INC
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE;ORAL Prescription No AB 091431 HERITAGE
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE;ORAL Prescription No AB 078466 LUPIN PHARMS
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE;ORAL Prescription No AB 077890 WATSON LABS

CAPSULE;ORAL; EQ 10MG BASE;20MG
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;20MG CAPSULE;ORAL Prescription No AB 202239 AUROBINDO PHARMA LTD
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE;ORAL Prescription No AB 077183 DR REDDYS LABS INC
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE;ORAL Prescription No AB 091431 HERITAGE
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE;ORAL Prescription No AB 078466 LUPIN PHARMS
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE;ORAL Prescription No AB 077890 WATSON LABS
Back to Top