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FDA BLA · BLA761064

RITUXAN HYCELA

rituximab and hyaluronidase

Sponsor: GENENTECH INC

APPLICATION
BLA761064
TYPE
BLA
ORIGINAL APPROVAL
2017-06-22
LATEST ACTION
2021-06-10
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

RITUXAN HYCELAPrescription
RITUXIMAB 1400MG and 23400UNITS/11.7ML, HYALURONIDASE (HUMAN RECOMBINANT) · SOLUTION · SUBCUTANEOUS
RITUXAN HYCELAPrescription
RITUXIMAB 1600MG and 26800UNITS/13.4ML, HYALURONIDASE (HUMAN RECOMBINANT) · SOLUTION · SUBCUTANEOUS

Approval history

2021-06-10Labeling · Supplement 13 · standard — Label ↗AP
2020-05-05Labeling · Supplement 10 · standard — Letter ↗AP
2020-05-05Labeling · Supplement 8 · standard — Letter ↗AP
2019-12-19Labeling · Supplement 9 · standard — Label ↗AP
2017-06-22Type 5 - New Formulation or New Manufacturer · Supplement 1 · standard — Label ↗AP
2017-06-22Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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