Purple Book product · Reference 351(a)
Gammaked, Gamunex-C
Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified
At a glance
Aug 27, 2003
Approved
Reference 351(a)
License type
Rx
Marketing
No
Patents listed
Key dates
Approval
Approval date of this BLA submission.
Aug 27, 2003
23 yr 1 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Sep 12, 2015
10 yr 11 mo ago
Today
Pharmaceutical detail
Strength
40G
Dosage form
Injection
Route
Subcutaneous
Presentation
Single-Use Bottle
Center
CBER
License number
1871
Product number
011
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.
- 2003Gammaked, Gamunex-CReference 351(a)
Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified · Grifols Therapeutics LLC
- 2003Gammaked, Gamunex-CReference 351(a)
Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified · Grifols Therapeutics LLC
- 2003Gammaked, Gamunex-CReference 351(a)
Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified · Grifols Therapeutics LLC
- 2003Gammaked, Gamunex-CReference 351(a)
Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified · Grifols Therapeutics LLC
- 2003Gammaked, Gamunex-CReference 351(a)
Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified · Grifols Therapeutics LLC
- 2003Gammaked, Gamunex-CReference 351(a)
Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified · Grifols Therapeutics LLC
- 2003Gammaked, Gamunex-CReference 351(a)
Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified · Grifols Therapeutics LLC
- 2003Gammaked, Gamunex-CReference 351(a)
Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified · Grifols Therapeutics LLC
- 2003Gammaked, Gamunex-CReference 351(a)
Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified · Grifols Therapeutics LLC
- 2003Gammaked, Gamunex-CReference 351(a)
Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified · Grifols Therapeutics LLC
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 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
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 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
