NDC 67457-845

OGIVRI

Trastuzumab

OGIVRI is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Trastuzumab.

Product ID67457-845_476fea90-ea21-4542-80eb-e3cf13653ad9
NDC67457-845
Product TypeHuman Prescription Drug
Proprietary NameOGIVRI
Generic NameTrastuzumab
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-11-29
Marketing CategoryBLA / BLA
Application NumberBLA761074
Labeler NameMylan Institutional LLC
Substance NameTRASTUZUMAB
Active Ingredient Strength420 mg/20mL
Pharm ClassesHER2/neu Receptor Antagonist [EPC],HER2/Neu/cerbB2 Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Drug Details

NDC Crossover Matching brand name "OGIVRI" or generic name "Trastuzumab"

NDCBrand NameGeneric Name
67457-845OGIVRItrastuzumab
67457-847OGIVRItrastuzumab
67457-991OGIVRItrastuzumab
50242-132HerceptinTrastuzumab
50242-134HerceptinTrastuzumab
50242-333HerceptinTrastuzumab
63459-303HERZUMATRASTUZUMAB
63459-305HERZUMATRASTUZUMAB
0006-5033Ontruzanttrastuzumab
0069-0305Trazimera-qyyptrastuzumab

Trademark Results [OGIVRI]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OGIVRI
OGIVRI
88650753 not registered Live/Pending
Mylan Institutional Inc.
2019-10-11
OGIVRI
OGIVRI
86970805 not registered Live/Pending
Mylan Institutional Inc.
2016-04-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.