Gazyva is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Obinutuzumab.
Product ID | 50242-070_6b5595ca-9d64-476e-9043-a7eeb1ca3858 |
NDC | 50242-070 |
Product Type | Human Prescription Drug |
Proprietary Name | Gazyva |
Generic Name | Obinutuzumab |
Dosage Form | Injection, Solution, Concentrate |
Route of Administration | INTRAVENOUS |
Marketing Start Date | 2013-11-01 |
Marketing Category | BLA / BLA |
Application Number | BLA125486 |
Labeler Name | Genentech, Inc. |
Substance Name | OBINUTUZUMAB |
Active Ingredient Strength | 1000 mg/40mL |
Pharm Classes | CD20-directed Antibody Interactions [MoA],CD20-directed Cytolytic Antibody [EPC] |
NDC Exclude Flag | N |
Listing Certified Through | 2020-12-31 |
Marketing Start Date | 2013-11-01 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | BLA |
Application Number | BLA125486 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2013-11-01 |
Marketing Category | BLA |
Application Number | BLA125486 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2013-11-04 |
Ingredient | Strength |
---|---|
OBINUTUZUMAB | 1000 mg/40mL |
SPL SET ID: | df12ceb2-5b4b-4ab5-a317-2a36bf2a3cda |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GAZYVA 97794811 not registered Live/Pending |
Genentech, Inc. 2023-02-14 |
GAZYVA 88672776 not registered Live/Pending |
Genentech, Inc. 2019-10-29 |
GAZYVA 85469227 4522383 Live/Registered |
GENENTECH, INC. 2011-11-10 |