STN: BL 103921
Proper Name: Tetanus and Diphtheria Toxoids Adsorbed For Adult Use
Manufacturer: Sanofi Pasteur, Inc, License #1725
- For active immunization for the prevention of tetanus and diptheria for use in persons 7 years of age or older.
March 7, 2011 Approval Letter - DECAVAC[ARCHIVED]
Revise the package insert to include additional safety and immunogenicity data obtained from the DECAVAC group of study Td506.
January 13, 2011 Approval Letter - DECAVAC[ARCHIVED]
Labeling revised to address latex hypersensitivity.
December 9, 2008 Approval Letter - DECAVAC[ARCHIVED]
To include editorial changes and updated data on spontaneously reported adverse events.
March 24, 2004 Approval Letter - DECAVAC[ARCHIVED]
Addition of a preservative-free, single dose Luer-Lok syringe presentation.
FDA Online Label Repository
Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.
Dear Health Care Provider: Important Information Re: Sanofi Pasteur's Adacel Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbe, and Decavac, Tetanus and Diphtheria Toxiods Adsorbed in Prefilled Syringes(PDF - 69KB)
October 27, 2010