Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016861
Company: AAIPHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DARVON-N PROPOXYPHENE NAPSYLATE 50MG/5ML SUSPENSION;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
09/09/1971 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/05/1994 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/15/1992 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

08/23/1994 SUPPL-22 Labeling

Label is not available on this site.

04/16/1987 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

10/16/1986 SUPPL-15 Labeling

Label is not available on this site.

08/26/1985 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/10/1985 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

04/21/1986 SUPPL-11 Labeling

Label is not available on this site.

08/20/1984 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

10/28/1981 SUPPL-9 Labeling

Label is not available on this site.

05/20/1981 SUPPL-8 Labeling

Label is not available on this site.

09/26/1979 SUPPL-6 Labeling

Label is not available on this site.

01/11/1978 SUPPL-5 Labeling

Label is not available on this site.

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