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Panhematin
Hemin for Injection
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Panhematin
Proper name
Hemin for Injection
Licence type
351(a)
BLA number
101246
Applicant
Recordati Rare Diseases, Inc.
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 350MG | For Injection | Intravenous | Single-Dose Vial | Rx | July 20, 1983 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | July 20, 1990 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |