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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Percutaneous
10,000AU/ML
Dropper Vial
351(a)
Disc
002
Injection
Subcutaneous
10,000AU/ML
Multi-Dose Vial
351(a)
Disc
Proper Name
Insects (Whole Body), Mite Dermatophagoides pteronyssinus
Insects (Whole Body), Mite Dermatophagoides pteronyssinus
BLA Number
101378
101378
Applicant
Allergy Laboratories, Inc.
Allergy Laboratories, Inc.
Original Approval Date
July 11, 1930
July 11, 1930
Date of First Licensure