Wyeth
Tetanus and Diphtheria Toxoids Adsorbed for Adult Use - Td Vaccine
Status: approval withdrawn
Organizations involved:
Wyeth – Manuf.; R&D; Tech.; Former
Cross ref: See the entry for a likely component of this combination vaccine, Tetanus Toxoids Adsorbed (#554). See the entries for Tetanus Toxoid Vaccines (#543); and Diphtheria Toxoid Products (#418).
Description: Tetanus and Diphtheria Toxoids Adsorbed for Adult Use is a combination vaccine formulated from Tetanus Toxoids Adsorbed and Diphtheria Toxoids Adsorbed.
Nomenclature: Tetanus & Diphtheria Toxoids/Wyeth [BIO]; Tetanus and Diphtheria Toxoids Adsorbed for Adult Use [FDA]; Tetanus and Diphtheria Toxoids Combined Alum Precipitated (for Adult Use) [FDA former]; TD Vaccine [SY]
Companies.: The product was manufactured by Wyeth Pharmaceuticals (Marietta, PA), CBER/FDA lic. no. 0003. It was marketed in the U.S. and, perhaps, internationally by Wyeth.
FDA class: Biologic PLA
CBER class: Multiple Antigen Preparations
Approvals: Date = 19541217; first approval; according to 1979 Office of Technology Assessment (OTA) vaccines approvals list
Date = 19700911, first approval; according to CBER/FDA database; However, an FDA letter on this date reports that the product license was revoked and granted (reissued) under the current FDA proper name.
Indications: product insert/labeling not available
Status: In Jan. 2001, Wyeth discontinued manufacture of all vaccines containing tetanus toxoid Wyeth closed its Marietta, PA, facility that manufactured this and other older vaccine products. Approval was voluntarily withdrawn.
Companies involvement:
Full monograph
559 Tetanus & Diphtheria Toxoids/
Nomenclature:
Tetanus & Diphtheria Toxoids/Wyeth [BIO]
Tetanus and Diphtheria Toxoids Adsorbed Purogenated for Adult Use [TR Purogenated is the reg. trademark]
Tetanus and Diphtheria Toxoids Adsorbed for Adult Use [FDA]
Tetanus and Diphtheria Toxoids Combined Aluminum Phosphate Adsorbed [or Alum Precipitated] [FDA former name replaced by current name in July 1970]
Td vaccine [SY]
NDC 0005-1875-31; NDC 0005-1875-47 [NUM NDC]
FDA Class: Biologic PLA
Year of approval (FDA) = 1954
Date of 1st FDA approval = 19541114
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
vaccines, bacterial
vaccines, combination
vaccines, toxoids (inactivated toxins)
bacterial culture <!-- bacterialculture -->
Clostridium tetani
Corynebacterium diphtheriae
Mueller and Miller medium
aluminum phosphate
Diphtheria Toxoid
formaldehyde
guinea pig potency test
LEDERJECT disposable syringes
Tetanus Toxoid
thimerosal (mercury derivative)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
FDA application withdrawn
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US011 Approved Formerly in US/withdrawn
EM999 Not Available/Not Marketed in EU
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