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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)
Rx
002
Injection
Intradermal
5,000AU/ML
Multi-Dose Vial
351(a)
Rx
003
Injection
Subcutaneous
5,000AU/ML
Multi-Dose Vial
351(a)
Rx
004
Injection
Intradermal
10,000AU/ML
Multi-Dose Vial
351(a)
Rx
005
Injection
Subcutaneous
10,000AU/ML
Multi-Dose Vial
351(a)
Rx
006
Injection
Intradermal
30,000AU/ML
Multi-Dose Vial
351(a)
Rx
007
Injection
Subcutaneous
30,000AU/ML
Multi-Dose Vial
351(a)
Rx
Proper Name
Insects (Whole Body), Mite Dermatophagoides farinae
BLA Number
101834
Applicant
Greer Laboratories, Inc.
Original Approval Date
September 15, 1958
Date of First Licensure
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