Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 018733
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TALWIN NX NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE EQ 0.5MG BASE;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No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
12/16/1982 ORIG-1 Approval Type 4 - New Combination 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
02/24/2011 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018733s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018733s015ltr.pdf
09/01/2008 SUPPL-14 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018733s014lbl.pdf
02/26/2003 SUPPL-12 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18733slr012ltr.pdf
02/29/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/12/1989 SUPPL-10 Labeling

Label is not available on this site.

02/02/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/09/1985 SUPPL-8 Labeling

Label is not available on this site.

01/12/1989 SUPPL-7 Labeling

Label is not available on this site.

04/05/1983 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/05/1983 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/05/1983 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/05/1983 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

04/05/1983 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/05/1983 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/24/2011 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018733s015lbl.pdf
09/01/2008 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018733s014lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English