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Product Number | Dosage Form | Route of Administration | Strength | Product Presentation | License Type | Proprietary Name | Marketing Status |
---|---|---|---|---|---|---|---|
001 | Injection | Subcutaneous | 50MG/0.5ML | Autoinjector | 351(a) | Simponi | Rx |
002 | Injection | Subcutaneous | 50MG/0.5ML | Pre-Filled Syringe | 351(a) | Simponi | Rx |
003 | Injection | Subcutaneous | 100MG/ML | Autoinjector | 351(a) | Simponi | Rx |
004 | Injection | Subcutaneous | 100MG/ML | Pre-Filled Syringe | 351(a) | Simponi | Rx |
Proper Name
golimumab
BLA Number
125289
Applicant
Janssen Biotech, Inc.
Original Approval Date
April 24, 2009
Date of First Licensure