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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intramuscular
2.5LF, 5LF, 2.5UG, 8UG/.5ML
Pre-Filled Syringe
351(a)
N/A
Rx
002
Injection
Intramuscular
2.5LF, 5LF, 2.5UG, 8UG/.5ML
Single-Dose Vial
351(a)
N/A
Rx
Proper Name
Tetanus and Diphtheria Toxoids Adsorbed
Tetanus and Diphtheria Toxoids Adsorbed
BLA Number
103921
103921
Applicant
Sanofi Vaccines US Inc.
Sanofi Vaccines US Inc.
Original Approval Date
December 9, 1999
December 9, 1999
Date of First Licensure