Drugs@FDA: FDA Approved Drug Products

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

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