Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010996
Company: XANODYNE PHARM

Products on NDA 010996

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DARVON COMPOUND	ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE	389MG;32.4MG;32MG	CAPSULE;ORAL	Discontinued	None	No	No
DARVON COMPOUND-65	ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE	389MG;32.4MG;65MG	CAPSULE;ORAL	Discontinued	None	No	No
DARVON W/ ASA	ASPIRIN; PROPOXYPHENE HYDROCHLORIDE	325MG;65MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 010996

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/12/1957	ORIG-1	Approval	Type 4 - New Combination	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/27/2004	SUPPL-68	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10996scm068ltr.pdf
02/24/1999	SUPPL-65	Manufacturing (CMC)		Label is not available on this site.
10/05/1998	SUPPL-64	Manufacturing (CMC)		Label is not available on this site.
08/10/1998	SUPPL-63	Manufacturing (CMC)-Control		Label is not available on this site.
04/06/1998	SUPPL-62	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/01/2002	SUPPL-61	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10996slr061,%2010997slr043,%2016862slr033ltr.pdf
09/15/1992	SUPPL-60	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/02/1994	SUPPL-58	Labeling		Label is not available on this site.
09/15/1992	SUPPL-57	Manufacturing (CMC)-Control		Label is not available on this site.
08/23/1994	SUPPL-55	Labeling		Label is not available on this site.
04/16/1987	SUPPL-48	Manufacturing (CMC)-Control		Label is not available on this site.
12/16/1986	SUPPL-47	Manufacturing (CMC)-Control		Label is not available on this site.
07/16/1986	SUPPL-42	Labeling		Label is not available on this site.
09/02/1986	SUPPL-41	Manufacturing (CMC)		Label is not available on this site.
04/21/1986	SUPPL-40	Labeling		Label is not available on this site.
04/21/1986	SUPPL-37	Labeling		Label is not available on this site.
01/28/1985	SUPPL-36	Manufacturing (CMC)-Control		Label is not available on this site.
03/08/1983	SUPPL-35	Manufacturing (CMC)-Formulation		Label is not available on this site.
10/28/1981	SUPPL-34	Labeling		Label is not available on this site.
10/28/1981	SUPPL-33	Labeling		Label is not available on this site.
05/20/1981	SUPPL-32	Labeling		Label is not available on this site.
04/16/1980	SUPPL-31	Labeling		Label is not available on this site.
09/26/1979	SUPPL-30	Labeling		Label is not available on this site.
07/17/1979	SUPPL-29	Labeling		Label is not available on this site.
03/26/1979	SUPPL-28	Labeling		Label is not available on this site.
10/13/1978	SUPPL-27	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/26/1978	SUPPL-26	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
01/18/1980	SUPPL-24	Manufacturing (CMC)-Control		Label is not available on this site.
05/03/1977	SUPPL-23	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/03/1977	SUPPL-22	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/23/1976	SUPPL-20	Labeling		Label is not available on this site.
01/06/1975	SUPPL-14	Labeling		Label is not available on this site.