Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077771
Company: HIKMA PHARMS

Products on ANDA 077771

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 077771

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/12/2011	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
02/27/2023	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/25/2015	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/25/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
11/18/2011	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.