Purple Book product · Biosimilar 351(k)
Nivestym
filgrastim-aafi
At a glance
Jul 20, 2018
Approved
Biosimilar 351(k)
License type
Rx
Marketing
No
Patents listed
Key dates
Approval
Approval date of this BLA submission.
Jul 20, 2018
8 yr ago
Today
Pharmaceutical detail
Strength
480MCG/0.8ML
Dosage form
Injection
Route
Subcutaneous
Presentation
Pre-Filled Syringe
Center
CDER
License number
1974
Product number
004
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyBiosimilar of filgrastim (Neupogen)
- 1991NeupogenReference 351(a)
filgrastim · Amgen Inc.
- 1991NeupogenReference 351(a)
filgrastim · Amgen Inc.
- 2000NeupogenReference 351(a)
filgrastim · Amgen Inc.
- 2000NeupogenReference 351(a)
filgrastim · Amgen Inc.
- 2018NivestymBiosimilar 351(k)
filgrastim-aafi · Hospira Inc., a Pfizer Company
- 2018NivestymBiosimilar 351(k)
filgrastim-aafi · Hospira Inc., a Pfizer Company
- 2018NivestymBiosimilar 351(k)
filgrastim-aafi · Hospira Inc., a Pfizer Company
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
Prescription
marketingStatus · Rx
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
