Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083978
Company: MYLAN

Products on ANDA 083978

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN	ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE	650MG;65MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 083978

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/25/1974	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
02/25/1998	SUPPL-212	Manufacturing (CMC)		Label is not available on this site.
02/05/1998	SUPPL-211	Manufacturing (CMC)		Label is not available on this site.
08/10/2000	SUPPL-210	Manufacturing (CMC)		Label is not available on this site.
03/07/1997	SUPPL-209	Manufacturing (CMC)		Label is not available on this site.
01/13/1994	SUPPL-208	Manufacturing (CMC)		Label is not available on this site.
10/31/1991	SUPPL-206	Manufacturing (CMC)		Label is not available on this site.
10/31/1991	SUPPL-205	Labeling		Label is not available on this site.
10/31/1991	SUPPL-204	Manufacturing (CMC)		Label is not available on this site.
01/31/1990	SUPPL-203	Manufacturing (CMC)		Label is not available on this site.
09/25/1986	SUPPL-200	Manufacturing (CMC)		Label is not available on this site.
06/28/1984	SUPPL-199	Manufacturing (CMC)		Label is not available on this site.
04/25/1983	SUPPL-198	Manufacturing (CMC)		Label is not available on this site.
06/08/1982	SUPPL-152	Manufacturing (CMC)		Label is not available on this site.