Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080269
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPOXYPHENE HYDROCHLORIDE 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
11/30/1971 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
07/29/2002 SUPPL-109 Manufacturing (CMC)-Facility

Label is not available on this site.

03/12/2002 SUPPL-108 Manufacturing (CMC)-Facility

Label is not available on this site.

09/21/2000 SUPPL-107 Manufacturing (CMC)-Control

Label is not available on this site.

09/21/2000 SUPPL-106 Manufacturing (CMC)-Facility

Label is not available on this site.

04/12/2000 SUPPL-105 Manufacturing (CMC)-Facility

Label is not available on this site.

01/28/2000 SUPPL-104 Manufacturing (CMC)-Facility

Label is not available on this site.

11/23/1999 SUPPL-103 Manufacturing (CMC)-Facility

Label is not available on this site.

08/20/1999 SUPPL-102 Manufacturing (CMC)

Label is not available on this site.

12/23/1998 SUPPL-101 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-100 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-99 Manufacturing (CMC)

Label is not available on this site.

10/29/1992 SUPPL-98 Manufacturing (CMC)

Label is not available on this site.

09/04/1992 SUPPL-97 Manufacturing (CMC)

Label is not available on this site.

02/26/1992 SUPPL-96 Labeling

Label is not available on this site.

06/11/1987 SUPPL-94 Manufacturing (CMC)

Label is not available on this site.

02/18/1987 SUPPL-93 Manufacturing (CMC)

Label is not available on this site.

02/18/1987 SUPPL-92 Manufacturing (CMC)

Label is not available on this site.

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