Purple Book product · Reference 351(a)
StrataGraft
Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat
At a glance
Jun 15, 2021
Approved
Reference 351(a)
License type
Disc
Marketing
No
Patents listed
Key dates
First licensure
Date the BLA was first licensed.
Jun 15, 2021
5 yr 1 mo ago
Approval
Approval date of this BLA submission.
Jun 15, 2021
5 yr 1 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Jun 15, 2028
in 2 yr 1 mo
Reference product exclusivity ends
12-year reference-product exclusivity window per BPCIA §351(k)(7).
Jun 15, 2033
in 7 yr 2 mo
Pharmaceutical detail
Strength
100CM SQUARED
Dosage form
Cell Sheets
Route
Topical
Presentation
Pouch
Center
CBER
License number
2144
Product number
001
Submission type
Original
Supplement number
0
Change type
Not listed
Reference product family
View full familyThis is the reference (originator) product. Biosimilars and interchangeables referencing it are listed below.
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 Biologics Evaluation and Research
center · CBER
application pathway
Biologics License Application
blaNumber · BLA
license type
351(a)
blaType · 351(a)
application pathway
Section 351(a) Biologic
blaType · 351(a)
product role
Reference or Standalone Biologic
blaType · Reference product
marketing status
Discontinued
marketingStatus · Disc
licensure status
Voluntarily Revoked
licensure · Voluntarily Revoked
source kind
Monthly Download
sourceKind · monthly_download
patent status
No Patent List Provided
patentListProvided · No patent list
exclusivity type
Reference Product Exclusivity
referenceProductExclusivityExpirationDate · Reference Product Exclusivity
- Food and Drug Administrationparent ofCenter for Biologics 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(a) Biologicmaps to351(a)
- 351(a)classifiesReference or Standalone Biologic
Source provenance
