Purple Book product · Reference 351(a)
Panhematin
Hemin for Injection
Jul 20, 1983
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 20, 1983
43 yr 7 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Jul 20, 1990
36 yr 6 mo ago
Today
Pharmaceutical detail
Strength
350MG
Dosage form
For Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CBER
License number
1899
Product number
001
Submission type
Supplement
Supplement number
5350
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.
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 Panhematin have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Panhematin are listed in the FDA Purple Book yet.
What is Panhematin's BLA number?
Panhematin is licensed under BLA 101246, held by Recordati Rare Diseases, Inc..
When was Panhematin approved by the FDA?
Panhematin was approved by the FDA on Jul 20, 1983.
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.
