Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083125
Company: SANDOZ
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
10/18/1972 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
10/14/1998 SUPPL-79 Manufacturing (CMC)

Label is not available on this site.

08/31/1990 SUPPL-78 Labeling

Label is not available on this site.

01/06/1989 SUPPL-77 Labeling

Label is not available on this site.

01/15/1988 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

01/15/1988 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

06/09/1987 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

04/29/1987 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

01/15/1987 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

02/15/1984 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

02/15/1984 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

08/11/1983 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

08/11/1983 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

08/11/1983 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

08/09/1982 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

06/10/1982 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

06/10/1982 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

08/09/1982 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

06/10/1982 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

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