Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074499
Company: SUN PHARM INDUSTRIES

Products on ANDA 074499

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ATENOLOL	ATENOLOL	25MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074499

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/30/1997	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
04/29/2015	SUPPL-34	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
10/24/2011	SUPPL-33	Labeling-Package Insert		Label is not available on this site.
03/15/2010	SUPPL-32	Labeling-Package Insert		Label is not available on this site.
08/26/2005	SUPPL-22	Labeling		Label is not available on this site.
05/03/2005	SUPPL-21	Labeling		Label is not available on this site.
07/24/2002	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
12/28/2001	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
02/19/2002	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
12/28/2001	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
09/05/2000	SUPPL-4	Labeling		Label is not available on this site.
05/16/2000	SUPPL-3	Manufacturing (CMC)-Facility		Label is not available on this site.
05/16/2000	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.
03/25/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.