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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018733
Company: SANOFI AVENTIS US

Products on NDA 018733

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HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018733

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.

Labels for NDA 018733

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

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