Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085795
Company: MUTUAL PHARM

Products on ANDA 085795

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;15MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 085795

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/20/1978	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
12/01/1998	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
09/24/1996	SUPPL-31	Labeling		Label is not available on this site.
12/23/1994	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
11/05/1991	SUPPL-26	Labeling		Label is not available on this site.
05/31/1990	SUPPL-25	Labeling		Label is not available on this site.
09/22/1988	SUPPL-23	Labeling		Label is not available on this site.
06/09/1989	SUPPL-22	Labeling		Label is not available on this site.
03/03/1988	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
03/03/1988	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
03/20/1987	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
02/17/1988	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
02/17/1988	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
02/17/1988	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
02/17/1988	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.