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Thyrogen
thyrotropin alfa
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Thyrogen
Proper name
thyrotropin alfa
Licence type
351(a)
BLA number
020898
Applicant
Genzyme Corporation
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 0.9MG | For Injection | Intramuscular | Single-Dose Vial | Rx | November 30, 1998 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | December 14, 2014 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |