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OGIVRI

trastuzumab · Kit

Prescription Biologic BLA
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information.

Overview

Brand name
OGIVRI
Generic name
trastuzumab
Dosage form
Kit
Route
—
Marketing category
BLA · BLA
Labeler
Mylan Institutional LLC
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
0
NDC product codes
2
Packages
2
Data completeness
52% of corroborating sources present

Forms, strengths and routes

Source: NDC Directory
Dosage form
Kit
Route of administration
—
Presentations
4

Regulatory status

Source: Drugs@FDANDC Directory
Application number
761074
Application type
BLA · Biologics License Application
Approval date
December 1, 2017
Sponsor
MYLAN GMBH
Products on application
1
Submissions recorded
5
Products approved under application 761074.
Product Trade name Form Strength Ingredient Status TE Flags
761074-001 OGIVRI INJECTABLE TRASTUZUMAB-DKST Prescription —

Approval history

Source: Drugs@FDA
Most recent submissions on application 761074.
Type No. Action Status Date Review
Supplement 30 Approved November 13, 2024 Standard
Supplement 27 Labeling Approved October 2, 2023 Standard
Supplement 5 Labeling Approved June 28, 2019 Standard
Supplement 4 Manufacturing (CMC) Approved April 17, 2019 Standard
Original application 1 Approved December 1, 2017 Standard

Review documents

  • 0 · Supplement · November 14, 2024
  • 0 · Supplement · November 14, 2024
  • 0 · Supplement · October 3, 2023
  • 0 · Supplement · October 3, 2023
  • 0 · Supplement · July 3, 2019
  • 0 · Supplement · April 23, 2019
  • 0 · Original application · January 30, 2019
  • 0 · Original application · November 29, 2018
  • 0 · Original application · December 1, 2017

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
83257-004-12 83257-004 Biocon Biologics Inc. 1 KIT in 1 CARTON (83257-004-12) * 20 mL in 1 VIAL, MULTI-DOSE (83257-003-11) * 20 mL in 1 VIAL (83257-002-11) October 1, 2023
67457-847-44 67457-847 Mylan Institutional LLC 1 KIT in 1 CARTON (67457-847-44) * 20 mL in 1 VIAL, MULTI-DOSE (67457-845-50) * 20 mL in 1 VIAL (67457-846-20) November 29, 2019
83257-004 83257-004 Biocon Biologics Inc. — October 1, 2023
67457-847 67457-847 Mylan Institutional LLC — November 29, 2019

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Purple Book FDA Biologic licence classification

Generated September 25, 2026 · 7 sections on this page.