Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076418
Company: MYLAN

Products on ANDA 076418

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 076418

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/03/2005	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
04/03/2018	SUPPL-20	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/25/2015	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
09/21/2014	SUPPL-16	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
03/22/2011	SUPPL-12	Labeling-Package Insert		Label is not available on this site.