Purple Book product · Reference 351(a)
Survanta
beractant
Jul 01, 1991
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.
Jul 01, 1991
35 yr 6 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Jul 02, 2098
in 73 yr
Pharmaceutical detail
Strength
100MG/4ML (25MG/ML)
Dosage form
Suspension
Route
Intratracheal
Presentation
Single-Dose Vial
Center
CDER
License number
1889
Product number
001
Submission type
Original
Supplement number
Not listed
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
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v2Jul 02, 2026
- v1Jul 02, 2026
Frequently asked questions
Does Survanta have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Survanta are listed in the FDA Purple Book yet.
What is Survanta's BLA number?
Survanta is licensed under BLA 20032, held by AbbVie Inc..
When was Survanta approved by the FDA?
Survanta was approved by the FDA on Jul 01, 1991.
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.
