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FDA Purple Book · Reference family

Botulism Antitoxin Bivalent (Equine) Types A and B.

Botulism Antitoxin Bivalent (Equine) Types A and B. is an FDA-licensed reference biologic from Sanofi Pasteur Limited. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2000

Reference approved

Reference product

351(a)BLA 103937

Not listed Botulism Antitoxin Bivalent (Equine) Types A and B.

Sanofi Pasteur Limited

Approved
Feb 24, 2000
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Botulism Antitoxin Bivalent (Equine) Types A and B., in chronological order.

  1. Reference approval

    Approval date of the reference Botulism Antitoxin Bivalent (Equine) Types A and B. product.

    26 yr 8 mo ago

Frequently asked questions

Are there biosimilars approved for Botulism Antitoxin Bivalent (Equine) Types A and B.?

No 351(k) biosimilars or interchangeable biosimilars referencing Botulism Antitoxin Bivalent (Equine) Types A and B. are listed in the FDA Purple Book yet.

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