Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018458
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TALACEN ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE 650MG;EQ 25MG 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
09/23/1982 ORIG-1 Approval Type 4 - New Combination 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
06/22/2011 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018458s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018458s016ltr.pdf
03/10/2011 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018458s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018458s014ltr.pdf
08/07/2008 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018458s013ltr.pdf
07/10/2003 SUPPL-12 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18458slr012ltr.pdf
10/31/2000 SUPPL-10 Labeling

Label is not available on this site.

03/30/2000 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/02/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/10/1988 SUPPL-7 Labeling

Label is not available on this site.

05/22/1987 SUPPL-6 Labeling

Label is not available on this site.

03/27/1987 SUPPL-5 Labeling

Label is not available on this site.

10/25/1985 SUPPL-4 Labeling

Label is not available on this site.

05/07/1985 SUPPL-3 Labeling

Label is not available on this site.

06/26/1984 SUPPL-2 Labeling

Label is not available on this site.

01/24/1984 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/22/2011 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018458s016lbl.pdf
03/10/2011 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018458s014lbl.pdf

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