NDC 0944-4627
ADYNOVATE
Antihemophilic Factor (recombinant) Pegylated
ADYNOVATE is a Kit in the Plasma Derivative category. It is labeled and distributed by Baxalta Us Inc.. The primary component is .
| Product ID | 0944-4627_2ce1e8b5-6151-4cfc-af08-b103c04befb5 |
| NDC | 0944-4627 |
| Product Type | Plasma Derivative |
| Proprietary Name | ADYNOVATE |
| Generic Name | Antihemophilic Factor (recombinant) Pegylated |
| Dosage Form | Kit |
| Marketing Start Date | 2015-11-13 |
| Marketing Category | BLA / BLA |
| Application Number | BLA125566 |
| Labeler Name | Baxalta US Inc. |
| Active Ingredient Strength | 0 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 0944-4627-01
1 KIT in 1 CARTON (0944-4627-01) > 1 CONTAINER in 1 KIT (0944-4627-02) > 1 KIT in 1 CONTAINER (0944-4627-03) * 5 mL in 1 VIAL, GLASS (0944-4141-01) * 2.5 mL in 1 VIAL
| Marketing Start Date | 2015-11-13 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0944-4627-03 [00944462703]
ADYNOVATE KIT
| Marketing Category | BLA |
| Application Number | BLA125566 |
| Product Type | PLASMA DERIVATIVE |
| Marketing Start Date | 2018-12-04 |
NDC 0944-4627-02 [00944462702]
ADYNOVATE KIT
| Marketing Category | BLA |
| Application Number | BLA125566 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | EA |
| Marketing Start Date | 2018-12-04 |
NDC 0944-4627-01 [00944462701]
ADYNOVATE KIT
| Marketing Category | BLA |
| Application Number | BLA125566 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | EA |
| Marketing Start Date | 2015-11-13 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-03-05 |
Drug Details
NDC Crossover Matching brand name "ADYNOVATE" or generic name "Antihemophilic Factor (recombinant) Pegylated"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0944-4132 | ADYNOVATE | antihemophilic factor (recombinant) pegylated |
| 0944-4133 | ADYNOVATE | antihemophilic factor (recombinant) pegylated |
| 0944-4134 | ADYNOVATE | antihemophilic factor (recombinant) pegylated |
| 0944-4135 | ADYNOVATE | antihemophilic factor (recombinant) pegylated |
| 0944-4136 | ADYNOVATE | antihemophilic factor (recombinant) pegylated |
| 0944-4252 | ADYNOVATE | antihemophilic factor (recombinant) pegylated |
| 0944-4254 | ADYNOVATE | antihemophilic factor (recombinant) pegylated |
| 0944-4256 | ADYNOVATE | antihemophilic factor (recombinant) pegylated |
| 0944-4258 | ADYNOVATE | antihemophilic factor (recombinant) pegylated |
| 0944-4260 | ADYNOVATE | antihemophilic factor (recombinant) pegylated |
| 0944-4262 | ADYNOVATE | antihemophilic factor (recombinant) pegylated |
| 0944-4264 | ADYNOVATE | antihemophilic factor (recombinant) pegylated |
| 0944-4622 | ADYNOVATE | Antihemophilic Factor (Recombinant) PEGylated |
| 0944-4623 | ADYNOVATE | Antihemophilic Factor (Recombinant) PEGylated |
| 0944-4624 | ADYNOVATE | Antihemophilic Factor (Recombinant) PEGylated |
| 0944-4625 | ADYNOVATE | Antihemophilic Factor (Recombinant) PEGylated |
| 0944-4626 | ADYNOVATE | Antihemophilic Factor (Recombinant) PEGylated |
| 0944-4627 | ADYNOVATE | Antihemophilic Factor (Recombinant) PEGylated |
| 0944-4628 | ADYNOVATE | Antihemophilic Factor (Recombinant) PEGylated |
Trademark Results [ADYNOVATE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ADYNOVATE 86561780 4942729 Live/Registered |
BAXALTA INCORPORATED 2015-03-12 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.