Purple Book reference family · 351(a) biologic
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed (Daptacel)
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed is an FDA-licensed reference biologic from Sanofi Vaccines Canada Ltd..
351(a) biologicBLA 103666 Sanofi Vaccines Canada Ltd.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2002
Reference product
Originator biologic
351(a)BLA 103666
Daptacel Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed
Sanofi Vaccines Canada Ltd.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed product.
24 yr 7 mo ago
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed.
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
