Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074203
Company: AUROBINDO PHARMA USA

Products on ANDA 074203

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE	50MG;25MG	TABLET;ORAL	Discontinued	None	No	No
ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE	100MG;25MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074203

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/1993	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
07/31/2015	SUPPL-23	Labeling-Container/Carton Labels		Label is not available on this site.
03/20/2009	SUPPL-18	Labeling		Label is not available on this site.
12/12/2005	SUPPL-11	Labeling		Label is not available on this site.
02/06/2004	SUPPL-10	Labeling		Label is not available on this site.
10/22/2003	SUPPL-9	Labeling		Label is not available on this site.
08/22/2002	SUPPL-8	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
08/14/2000	SUPPL-7	Labeling		Label is not available on this site.
06/07/2000	SUPPL-6	Labeling		Label is not available on this site.
12/28/1998	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/05/1998	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/03/1997	SUPPL-3	Labeling		Label is not available on this site.
09/18/1996	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
08/31/1994	SUPPL-1	Labeling		Label is not available on this site.