Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 081079
Company: WATSON LABS

Products on ANDA 081079

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	500MG;2.5MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 081079

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/30/1991	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
01/09/2008	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
08/08/2002	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
08/08/2002	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
05/21/2002	SUPPL-14	Manufacturing (CMC)-Facility		Label is not available on this site.
09/05/2001	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
03/29/2000	SUPPL-12	Labeling		Label is not available on this site.
10/29/1998	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
10/07/1998	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
12/04/1997	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
12/04/1997	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
08/08/1997	SUPPL-7	Labeling		Label is not available on this site.
12/04/1997	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
05/10/1996	SUPPL-4	Labeling		Label is not available on this site.
12/22/1995	SUPPL-3	Labeling		Label is not available on this site.
10/20/1994	SUPPL-2	Labeling		Label is not available on this site.
09/08/1992	SUPPL-1	Labeling		Label is not available on this site.