Flebogamma DIF is a Intravenous Injection, Solution in the Plasma Derivative category. It is labeled and distributed by Grifols Usa, Llc. The primary component is Human Immunoglobulin G.
Product ID | 61953-0004_1f8c566e-d36b-469d-b6e0-ba2011a8b1f8 |
NDC | 61953-0004 |
Product Type | Plasma Derivative |
Proprietary Name | Flebogamma DIF |
Generic Name | Immune Globulin (human) |
Dosage Form | Injection, Solution |
Route of Administration | INTRAVENOUS |
Marketing Start Date | 2006-12-21 |
Marketing Category | BLA / BLA |
Application Number | BLA125077 |
Labeler Name | GRIFOLS USA, LLC |
Substance Name | HUMAN IMMUNOGLOBULIN G |
Active Ingredient Strength | 0 g/mL |
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 | 2006-12-21 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | BLA |
Application Number | BLA125077 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 2012-11-14 |
Marketing Category | BLA |
Application Number | BLA125077 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 2006-12-21 |
Marketing Category | BLA |
Application Number | BLA125077 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 2012-11-14 |
Marketing Category | BLA |
Application Number | BLA125077 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 2006-12-21 |
Marketing Category | BLA |
Application Number | BLA125077 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 2012-11-14 |
Marketing Category | BLA |
Application Number | BLA125077 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 2006-12-21 |
Marketing Category | BLA |
Application Number | BLA125077 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 2006-12-21 |
Marketing Category | BLA |
Application Number | BLA125077 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 2012-11-14 |
Marketing Category | BLA |
Application Number | BLA125077 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 2006-12-21 |
Marketing Category | BLA |
Application Number | BLA125077 |
Product Type | PLASMA DERIVATIVE |
Billing Unit | ML |
Marketing Start Date | 2012-11-14 |
Ingredient | Strength |
---|---|
HUMAN IMMUNOGLOBULIN G | .05 g/mL |
NDC | Brand Name | Generic Name |
---|---|---|
61953-0005 | FLEBOGAMMA DIF | IMMUNE GLOBULIN INTRAVENOUS (HUMAN) |
61953-0004 | Flebogamma | Immune Globulin (Human) |
13533-335 | GamaSTAN | immune globulin (human) |
13533-635 | GAMASTAN | IMMUNE GLOBULIN (HUMAN) |
76125-900 | GAMMAKED | Immune Globulin (Human) |
13533-800 | Gamunex-C | Immune Globulin (Human) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FLEBOGAMMA 76129679 2595626 Live/Registered |
GRIFOLS, S.A. 2000-09-18 |