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Histatrol
Positive Skin Test Control-Histamine
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Histatrol
Proper name
Positive Skin Test Control-Histamine
Licence type
351(a)
BLA number
103754
Applicant
ALK-Abello, Inc.
Center
CBER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 0.1MG/ML | Injection | Intradermal | Multi-Dose Vial | Rx | September 29, 1950 |
| 1MG/ML | Injection | Percutaneous | Multi-Dose Vial | Rx | September 29, 1950 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |