Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089959
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE 650MG;65MG TABLET;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
07/18/1989 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/08/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/11/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/28/1993 SUPPL-5 Labeling

Label is not available on this site.

05/17/1991 SUPPL-4 Labeling

Label is not available on this site.

04/07/1992 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/22/1990 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/26/1989 SUPPL-1 Labeling

Label is not available on this site.

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