Purple Book product · Biosimilar 351(k)
Herzuma
trastuzumab-pkrb
At a glance
May 16, 2019
Approved
Biosimilar 351(k)
License type
Rx
Marketing
No
Patents listed
Key dates
Approval
Approval date of this BLA submission.
May 16, 2019
7 yr 2 mo ago
Today
Pharmaceutical detail
Strength
150MG
Dosage form
For injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
1996
Product number
002
Submission type
Supplement
Supplement number
1
Change type
Not listed
Reference product family
View full familyBiosimilar of trastuzumab (Herceptin)
Patent list (4)
Taxonomy and ontology
11 termscenter
Center for Drug Evaluation and Research
center · CDER
application pathway
Biologics License Application
blaNumber · BLA
license type
351(k) Biosimilar
blaType · 351(k) Biosimilar
application pathway
Section 351(k) Biosimilar or Interchangeable
blaType · 351(k)
product role
Biosimilar
blaType · Biosimilar
marketing status
Prescription
marketingStatus · Rx
licensure status
Licensed
licensure · Licensed
route
Intravenous
routeOfAdministration · Intravenous
dosage form
For Injection
dosageForm · For injection
source kind
Monthly Download
sourceKind · monthly_download
- Food and Drug Administrationparent ofCenter for Drug Evaluation and Research
- Food and Drug Administrationsource forMonthly Download
- Biologics License Applicationparent ofSection 351(a) Biologic
- Biologics License Applicationparent ofSection 351(k) Biosimilar or Interchangeable
- Section 351(k) Biosimilar or Interchangeablemaps to351(k) Biosimilar
- Section 351(k) Biosimilar or Interchangeablemaps to351(k) Interchangeable
Source provenance
