Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073353
Company: WATSON LABS TEVA

Products on ANDA 073353

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ATENOLOL	ATENOLOL	100MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 073353

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/27/1991	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
12/13/2006	SUPPL-26	Labeling		Label is not available on this site.
06/22/2006	SUPPL-25	Labeling		Label is not available on this site.
09/25/2003	SUPPL-22	Labeling		Label is not available on this site.
03/30/2001	SUPPL-19	Labeling		Label is not available on this site.
04/25/2001	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
08/07/2000	SUPPL-17	Labeling		Label is not available on this site.
12/15/1997	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
12/15/1997	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
06/23/1997	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
11/25/1996	SUPPL-11	Labeling		Label is not available on this site.
11/08/1994	SUPPL-10	Labeling		Label is not available on this site.
03/31/1994	SUPPL-9	Labeling		Label is not available on this site.
07/22/1993	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
05/05/1993	SUPPL-6	Labeling		Label is not available on this site.
12/07/1992	SUPPL-3	Labeling		Label is not available on this site.
07/06/1992	SUPPL-2	Labeling		Label is not available on this site.
07/22/1992	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.