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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Percutaneous
10,000BAU/ML
Dropper Vial
351(a)
Rx
002
Injection
Intradermal
10,000BAU/ML
Multi-Dose Vial
351(a)
Rx
003
Injection
Subcutaneous
10,000BAU/ML
Multi-Dose Vial
351(a)
Rx
004
Injection
Percutaneous
100,000BAU/ML
Dropper Vial
351(a)
Rx
005
Injection
Intradermal
100,000BAU/ML
Multi-Dose Vial
351(a)
Rx
006
Injection
Subcutaneous
100,000BAU/ML
Multi-Dose Vial
351(a)
Rx
Proper Name
Pollens - Grasses, Orchard Grass Dactylis glomerata
Pollens - Grasses, Orchard Grass Dactylis glomerata
BLA Number
101839
101839
Applicant
Greer Laboratories, Inc.
Greer Laboratories, Inc.
Original Approval Date
June 14, 1930
June 14, 1930
Date of First Licensure