Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016732
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TALWIN 50 PENTAZOCINE HYDROCHLORIDE EQ 50MG BASE TABLET;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
02/03/1969 ORIG-1 Approval Type 2 - New Active Ingredient PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/19/1982 SUPPL-51 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/02/1981 SUPPL-47 Labeling

Label is not available on this site.

01/09/1981 SUPPL-46 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/02/1980 SUPPL-45 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/19/1980 SUPPL-44 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/05/1979 SUPPL-43 Labeling

Label is not available on this site.

07/23/1979 SUPPL-42 Labeling

Label is not available on this site.

05/31/1979 SUPPL-41 Labeling

Label is not available on this site.

04/30/1979 SUPPL-40 Labeling

Label is not available on this site.

04/11/1979 SUPPL-39 Labeling

Label is not available on this site.

11/06/1978 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

11/28/1978 SUPPL-37 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/28/1977 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

08/30/1977 SUPPL-35 Labeling

Label is not available on this site.

05/11/1977 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

07/16/1976 SUPPL-33 Labeling

Label is not available on this site.

10/31/1975 SUPPL-30 Labeling

Label is not available on this site.

07/30/1975 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

07/30/1975 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

04/03/1975 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

09/26/1974 SUPPL-26 Labeling

Label is not available on this site.

12/09/1974 SUPPL-25 Labeling

Label is not available on this site.

11/08/1974 SUPPL-22 Labeling

Label is not available on this site.

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