Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016863
Company: AAIPHARMA LLC

Products on NDA 016863

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DARVON-N W/ ASA	ASPIRIN; PROPOXYPHENE NAPSYLATE	325MG;100MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016863

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/09/1971	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/15/1992	SUPPL-25	Manufacturing (CMC)-Control		Label is not available on this site.
08/23/1994	SUPPL-24	Labeling		Label is not available on this site.
04/15/1987	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
10/16/1986	SUPPL-18	Labeling		Label is not available on this site.
04/21/1986	SUPPL-15	Labeling		Label is not available on this site.
08/20/1984	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
10/28/1981	SUPPL-13	Labeling		Label is not available on this site.
05/20/1981	SUPPL-12	Labeling		Label is not available on this site.
04/15/1980	SUPPL-11	Labeling		Label is not available on this site.
09/26/1979	SUPPL-10	Labeling		Label is not available on this site.
01/11/1980	SUPPL-9	Manufacturing (CMC)-Formulation		Label is not available on this site.
01/11/1978	SUPPL-8	Labeling		Label is not available on this site.
10/13/1977	SUPPL-7	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/13/1977	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/21/1980	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.