Purple Book product · Reference 351(a)
Biothrax
Anthrax Vaccine Adsorbed
Nov 12, 1998
Approved
Reference 351(a)
License type
Rx
Marketing
None
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
Nov 12, 1998
28 yr 1 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Nov 23, 2022
3 yr 8 mo ago
Today
Pharmaceutical detail
Strength
0.5ML
Dosage form
Injection
Route
Intramuscular
Presentation
Multi-Dose Vial
Center
CBER
License number
1755
Product number
001
Submission type
Original
Supplement number
0
Change type
Not listed
Reference product family
View full familyThis is the reference (originator) product. No biosimilars or interchangeables reference it in the Purple Book yet.
1 additional BLA record for this product (other strengths or presentations) are in the same reference family.
Patent list
No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.
Source provenance
- advanced-searchAdvanced Search · Jul 02, 2026
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v6Jul 02, 2026
- v5Jul 02, 2026
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Frequently asked questions
Does Biothrax have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Biothrax are listed in the FDA Purple Book yet.
What is Biothrax's BLA number?
Biothrax is licensed under BLA 103821, held by Emergent BioDefense Operations Lansing LLC.
When was Biothrax approved by the FDA?
Biothrax was approved by the FDA on Nov 12, 1998.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
