NDC 0944-3052
ADVATE
Antihemophilic Factor (recombinant)
ADVATE is a Kit in the Plasma Derivative category. It is labeled and distributed by Baxalta Us Inc.. The primary component is .
| Product ID | 0944-3052_2da612a3-e4f0-4190-9467-be7df2c98028 |
| NDC | 0944-3052 |
| Product Type | Plasma Derivative |
| Proprietary Name | ADVATE |
| Generic Name | Antihemophilic Factor (recombinant) |
| Dosage Form | Kit |
| Marketing Start Date | 2011-12-15 |
| Marketing Category | BLA / BLA |
| Application Number | BLA125063 |
| Labeler Name | Baxalta US Inc. |
| Active Ingredient Strength | 0 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
Packaging
NDC 0944-3052-02
1 BLISTER PACK in 1 CARTON (0944-3052-02) > 1 CONTAINER in 1 BLISTER PACK (0944-3052-03) > 1 KIT in 1 CONTAINER (0944-3052-04) * 5 mL in 1 VIAL, GLASS (0944-2942-02) * 2 mL in 1 VIAL, GLASS
| Marketing Start Date | 2011-12-15 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0944-3052-04 [00944305204]
Advate KIT
| Marketing Category | BLA |
| Application Number | BLA125063 |
| Product Type | PLASMA DERIVATIVE |
| Marketing Start Date | 2011-12-15 |
NDC 0944-3052-03 [00944305203]
Advate KIT
| Marketing Category | BLA |
| Application Number | BLA125063 |
| Product Type | PLASMA DERIVATIVE |
| Marketing Start Date | 2011-12-15 |
NDC 0944-3052-02 [00944305202]
Advate KIT
| Marketing Category | BLA |
| Application Number | BLA125063 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | EA |
| Marketing Start Date | 2011-12-15 |
Drug Details
NDC Crossover Matching brand name "ADVATE" or generic name "Antihemophilic Factor (recombinant)"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0944-3045 | ADVATE | ADVATE |
| 0944-3052 | ADVATE | ADVATE |
| 0944-3053 | ADVATE | ADVATE |
| 0944-3051 | ADVATE | ADVATE |
| 0944-3054 | ADVATE | ADVATE |
| 0944-3047 | ADVATE | ADVATE |
| 0944-3046 | ADVATE | ADVATE |
| 0026-3782 | Kogenate FS | Antihemophilic Factor (Recombinant) |
| 0026-3783 | Kogenate FS | Antihemophilic Factor (Recombinant) |
| 0026-3785 | Kogenate FS | Antihemophilic Factor (Recombinant) |
| 0026-3786 | Kogenate FS | Antihemophilic Factor (Recombinant) |
| 0026-3787 | Kogenate FS | Antihemophilic Factor (Recombinant) |
| 0026-3821 | Kovaltry | Antihemophilic Factor (Recombinant) |
| 0026-3822 | Kovaltry | Antihemophilic Factor (Recombinant) |
| 0026-3824 | Kovaltry | Antihemophilic Factor (Recombinant) |
Trademark Results [ADVATE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ADVATE 78075589 2867685 Live/Registered |
BAXALTA INCORPORATED 2001-07-25 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.