Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010997
Company: XANODYNE PHARM

• Medication Guide

Products on NDA 010997

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DARVON	PROPOXYPHENE HYDROCHLORIDE	32MG	CAPSULE;ORAL	Discontinued	None	No	No
DARVON	PROPOXYPHENE HYDROCHLORIDE	65MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 010997

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/16/1957	ORIG-1	Approval	Type 1 - New Molecular Entity	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
09/25/2009	SUPPL-52	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010997s051s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010997s051,052,016862s041,042,017122s061,062ltr.pdf
09/25/2009	SUPPL-51	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010997s051s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010997s051,052,016862s041,042,017122s061,062ltr.pdf
02/24/1999	SUPPL-47	Manufacturing (CMC)		Label is not available on this site.
10/05/1998	SUPPL-46	Manufacturing (CMC)		Label is not available on this site.
08/10/1998	SUPPL-45	Manufacturing (CMC)-Control		Label is not available on this site.
04/02/1998	SUPPL-44	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/01/2002	SUPPL-43	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10996slr061,%2010997slr043,%2016862slr033ltr.pdf
09/02/1994	SUPPL-42	Labeling		Label is not available on this site.
09/15/1992	SUPPL-41	Manufacturing (CMC)-Control		Label is not available on this site.
08/23/1994	SUPPL-40	Labeling		Label is not available on this site.
12/08/1986	SUPPL-35	Manufacturing (CMC)-Control		Label is not available on this site.
10/16/1986	SUPPL-33	Labeling		Label is not available on this site.
11/05/1986	SUPPL-32	Manufacturing (CMC)-Control		Label is not available on this site.
04/21/1986	SUPPL-31	Labeling		Label is not available on this site.
04/21/1986	SUPPL-28	Labeling		Label is not available on this site.
04/21/1986	SUPPL-27	Labeling		Label is not available on this site.
01/28/1985	SUPPL-26	Manufacturing (CMC)-Control		Label is not available on this site.
10/28/1981	SUPPL-25	Labeling		Label is not available on this site.
05/20/1981	SUPPL-24	Labeling		Label is not available on this site.
08/10/1981	SUPPL-23	Manufacturing (CMC)-Formulation		Label is not available on this site.
04/15/1980	SUPPL-22	Labeling		Label is not available on this site.
09/26/1979	SUPPL-21	Labeling		Label is not available on this site.
10/13/1978	SUPPL-20	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/26/1978	SUPPL-19	Manufacturing (CMC)-Formulation		Label is not available on this site.
02/27/1979	SUPPL-18	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
01/21/1980	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
05/03/1977	SUPPL-15	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/03/1977	SUPPL-14	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/23/1976	SUPPL-13	Labeling		Label is not available on this site.
01/06/1975	SUPPL-10	Labeling		Label is not available on this site.

Labels for NDA 010997

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/25/2009	SUPPL-52	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010997s051s052lbl.pdf
09/25/2009	SUPPL-51	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010997s051s052lbl.pdf