Purple Book product · Biosimilar 351(k)
Retacrit
epoetin alfa-epbx
At a glance
May 15, 2018
Approved
Biosimilar 351(k)
License type
Rx
Marketing
No
Patents listed
Key dates
Approval
Approval date of this BLA submission.
May 15, 2018
8 yr 2 mo ago
Today
Pharmaceutical detail
Strength
4,000UNITS/ML
Dosage form
Injection
Route
Intravenous, Subcutaneous
Presentation
Single-Dose Vial
Center
CDER
License number
1974
Product number
003
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyBiosimilar of epoetin alfa (Procrit)
- 1989Epogen/ProcritReference 351(a)
epoetin alfa · Amgen Inc.
- —Epogen/ProcritReference 351(a)
epoetin alfa · Amgen Inc.
- —Epogen/ProcritReference 351(a)
epoetin alfa · Amgen Inc.
- 1989Epogen/ProcritReference 351(a)
epoetin alfa · Amgen Inc.
- 1989Epogen/ProcritReference 351(a)
epoetin alfa · Amgen Inc.
- —ProcritReference 351(a)
epoetin alfa · Amgen Inc.
- 1989Epogen/ProcritReference 351(a)
epoetin alfa · Amgen Inc.
- 2018RetacritBiosimilar 351(k)
epoetin alfa-epbx · Hospira Inc., a Pfizer Company
- 2018RetacritBiosimilar 351(k)
epoetin alfa-epbx · Hospira Inc., a Pfizer Company
- 2018RetacritBiosimilar 351(k)
epoetin alfa-epbx · Hospira Inc., a Pfizer Company
- 2018RetacritBiosimilar 351(k)
epoetin alfa-epbx · Hospira Inc., a Pfizer Company
- 2020RetacritBiosimilar 351(k)
epoetin alfa-epbx · 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
10 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
dosage form
Injection
dosageForm · Injection
source kind
Monthly Download
sourceKind · monthly_download
patent status
No Patent List Provided
patentListProvided · No patent list
- 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
