Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083101
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPOXYPHENE COMPOUND-65 ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE 389MG;32.4MG;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
06/15/1976 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
04/04/1995 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

03/27/1992 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

09/12/1989 SUPPL-64 Labeling

Label is not available on this site.

06/08/1989 SUPPL-63 Labeling

Label is not available on this site.

06/14/1991 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

05/21/1987 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

05/21/1987 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

08/01/1986 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

08/01/1986 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

08/19/1985 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

06/20/1984 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

06/20/1984 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

06/24/1985 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

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