Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070115
Company: MUTUAL PHARM

Products on ANDA 070115

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE	325MG;50MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070115

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/12/1985	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-24	Manufacturing (CMC)		Label is not available on this site.
12/23/1994	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
05/07/1990	SUPPL-19	Bioequivalence		Label is not available on this site.
05/01/1991	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
07/12/1989	SUPPL-17	Labeling		Label is not available on this site.
02/28/1989	SUPPL-16	Labeling		Label is not available on this site.
03/27/1987	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/21/1987	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
12/11/1985	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
12/11/1985	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
12/30/1985	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
12/30/1985	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/18/1985	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.