Purple Book product · Biosimilar 351(k)
Ixifi
infliximab-qbtx
At a glance
Dec 13, 2017
Approved
Biosimilar 351(k)
License type
Disc
Marketing
No
Patents listed
Key dates
Approval
Approval date of this BLA submission.
Dec 13, 2017
8 yr 7 mo ago
Today
Pharmaceutical detail
Strength
100MG
Dosage form
For Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
2060
Product number
001
Submission type
Original
Supplement number
Not listed
Change type
U
Reference product family
View full familyBiosimilar of infliximab (Remicade)
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
12 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
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
