FDA BLA 103705, RITUXAN, Genentech, 11/26/1997

Contents: Summary Basis of Approval (SBA) and supporting safety and efficacy data, clinical study research protocols, supplemental data, and any other documentation associated with the original approval of: Rituxan (rituximab), BLA 97-0244, (BLA): 103705 submitted by Genentech, Inc., in 1997.

BLA: 103705
Company: Genentech
Drug Name: RITUXAN
Active Ingredients: RITUXIMAB
Strength: 100MG/10ML (10MG/ML)
Dosage Form/Route: SOLUTION;INTRAVENOUSPrescription
Action Date: 11/26/1997
Marketing Status: Prescription
Submission Classification: ORIG-1
Action Date: None

54 pages

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