Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 18458

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

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