Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077375
Company: MYLAN

Products on ANDA 077375

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	Discontinued	None	No	No
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE;ORAL	Discontinued	None	No	No
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE;ORAL	Discontinued	None	No	No
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077375

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/21/2010	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
08/16/2021	SUPPL-14	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert		Label is not available on this site.
08/16/2021	SUPPL-13	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
02/21/2020	SUPPL-11	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
01/04/2016	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
01/04/2016	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
01/04/2016	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
11/04/2014	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
12/31/2011	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
10/21/2011	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.