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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090364
Company: WATSON LABS INC

Products on ANDA 090364

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090364

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-Package Insert, Labeling-Patient 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.

Therapeutic Equivalents for ANDA 090364

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	SANDOZ

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	SANDOZ

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