GAMMAKED is a Intravenous; Subcutaneous Injection in the Plasma Derivative category. It is labeled and distributed by Kedrion Biopharma, Inc.. The primary component is Human Immunoglobulin G.
Product ID | 76125-900_a7164c72-baa7-4e49-a763-e5c75478ce2f |
NDC | 76125-900 |
Product Type | Plasma Derivative |
Proprietary Name | GAMMAKED |
Generic Name | Immune Globulin (human) |
Dosage Form | Injection |
Route of Administration | INTRAVENOUS; SUBCUTANEOUS |
Marketing Start Date | 2010-10-13 |
Marketing Category | BLA / BLA |
Application Number | BLA125046 |
Labeler Name | KEDRION BIOPHARMA, INC. |
Substance Name | HUMAN IMMUNOGLOBULIN G |
Active Ingredient Strength | 10 g/100mL |
Pharm Classes | Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS] |
NDC Exclude Flag | N |
Listing Certified Through | 2020-12-31 |
Marketing Start Date | 2010-10-13 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | BLA |
Application Number | BLA125046 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 2010-10-13 |
Marketing Category | BLA |
Application Number | BLA125046 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 2010-10-13 |
Marketing Category | BLA |
Application Number | BLA125046 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 2010-10-13 |
Marketing Category | BLA |
Application Number | BLA125046 |
Product Type | PLASMA DERIVATIVE |
Marketing Start Date | 2013-01-07 |
Marketing Category | BLA |
Application Number | BLA125046 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 2013-01-07 |
Marketing Category | BLA |
Application Number | BLA125046 |
Product Type | PLASMA DERIVATIVE |
Marketing Start Date | 2013-01-07 |
Marketing Category | BLA |
Application Number | BLA125046 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 2010-10-13 |
Marketing Category | BLA |
Application Number | BLA125046 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 2013-01-07 |
Marketing Category | BLA |
Application Number | BLA125046 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 2013-01-07 |
Marketing Category | BLA |
Application Number | BLA125046 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 2010-10-13 |
Ingredient | Strength |
---|---|
HUMAN IMMUNOGLOBULIN G | 10 g/100mL |
NDC | Brand Name | Generic Name |
---|---|---|
76125-900 | GAMMAKED | Immune Globulin (Human) |
61953-0004 | Flebogamma | Immune Globulin (Human) |
13533-335 | GamaSTAN | immune globulin (human) |
13533-635 | GAMASTAN | IMMUNE GLOBULIN (HUMAN) |
13533-800 | Gamunex-C | Immune Globulin (Human) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GAMMAKED 85359561 4207375 Live/Registered |
KEDRION S.p.A. 2011-06-29 |