Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083501
Company: WEST WARD
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
06/20/1973 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
08/08/2002 SUPPL-40 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/08/2002 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/08/2002 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/2002 SUPPL-37 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

08/08/2002 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

03/12/1999 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

10/01/1998 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

09/30/1993 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

10/07/1992 SUPPL-32 Labeling

Label is not available on this site.

07/22/1992 SUPPL-31 Labeling

Label is not available on this site.

03/19/1991 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

04/06/1988 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

03/03/1988 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

03/03/1988 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

03/03/1988 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

03/03/1988 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/03/1988 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/02/1989 SUPPL-23 Labeling

Label is not available on this site.

01/11/1991 SUPPL-22 Labeling

Label is not available on this site.

01/11/1991 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/11/1991 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/11/1991 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

02/21/1989 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

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