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FDA Drug/Biologics Approval BLA 761064, RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT)
FDA Drug/Biologics Approval BLA 761064, RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT)
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BLA 761064
Company: GENENTECH INC
Drug Name: RITUXAN HYCELA
Active Ingredients: RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT)
Strength: 1600MG and 26800UNITS/13.4ML
Dosage Form/Route: SOLUTION;SUBCUTANEOUS
Action Date: 06/22/2017
Marketing Status: Prescription
Submission Classification: ORIG-1
Company: GENENTECH INC
Drug Name: RITUXAN HYCELA
Active Ingredients: RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT)
Strength: 1600MG and 26800UNITS/13.4ML
Dosage Form/Route: SOLUTION;SUBCUTANEOUS
Action Date: 06/22/2017
Marketing Status: Prescription
Submission Classification: ORIG-1
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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