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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018458
Company: SANOFI AVENTIS US

Products on NDA 018458

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018458

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.

Labels for NDA 018458

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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