Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078477
Company: AMNEAL PHARMS NY

Products on ANDA 078477

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET;ORAL	Discontinued	None	No	No
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET;ORAL	Discontinued	None	No	No
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078477

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/16/2008	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
04/05/2018	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
11/24/2015	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
09/26/2014	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
07/26/2011	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
11/01/2011	SUPPL-12	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
05/27/2010	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
11/01/2011	SUPPL-6	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
11/01/2011	SUPPL-5	Labeling		Label is not available on this site.