Drugs@FDA: FDA Approved Drug Products

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

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

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