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Baytet, Hypertet
Tetanus Immune Globulin (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Baytet, Hypertet
Proper name
Tetanus Immune Globulin (Human)
Licence type
351(a)
BLA number
101142
Applicant
Grifols Therapeutics LLC
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 250U | Injection | Intramuscular | Pre-Filled Syringe | Rx | October 17, 1957 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |