Purple Book product · Biosimilar 351(k)
Erelzi
etanercept-szzs
At a glance
Aug 30, 2016
Approved
Biosimilar 351(k)
License type
Disc
Marketing
No
Patents listed
Key dates
Approval
Approval date of this BLA submission.
Aug 30, 2016
9 yr 11 mo ago
Today
Pharmaceutical detail
Strength
25MG/0.5ML
Dosage form
Injection
Route
Subcutaneous
Presentation
Pre-Filled Syringe
Center
CDER
License number
2003
Product number
001
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyBiosimilar of etanercept (Enbrel)
- 1998EnbrelReference 351(a)
etanercept · Immunex Corporation
- 1999EnbrelReference 351(a)
etanercept · Immunex Corporation
- 2004EnbrelReference 351(a)
etanercept · Immunex Corporation
- 2007EnbrelReference 351(a)
etanercept · Immunex Corporation
- 2017Enbrel MiniReference 351(a)
etanercept · Immunex Corporation
- —EnbrelReference 351(a)
etanercept · Immunex Corporation
- 2020EnbrelReference 351(a)
etanercept · Immunex Corporation
- 2016ErelziBiosimilar 351(k)
etanercept-szzs · Sandoz Inc.
- 2016Erelzi SensoreadyBiosimilar 351(k)
etanercept-szzs · Sandoz Inc.
- 2022ErelziBiosimilar 351(k)
etanercept-szzs · Sandoz Inc.
Patent list
No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.
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
Discontinued
marketingStatus · Disc
licensure status
Licensed
licensure · Licensed
route
Subcutaneous
routeOfAdministration · Subcutaneous
dosage form
Injection
dosageForm · 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
