ANDEXXA is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Andexanet Alfa.
Product ID | 0310-3200_2d9d90a6-63e6-46ef-96ff-dd6519ae7b6c |
NDC | 0310-3200 |
Product Type | Human Prescription Drug |
Proprietary Name | ANDEXXA |
Generic Name | Andexanet Alfa |
Dosage Form | Injection, Powder, Lyophilized, For Solution |
Route of Administration | INTRAVENOUS |
Marketing Start Date | 2022-07-12 |
Marketing Category | BLA / |
Application Number | BLA125586 |
Labeler Name | AstraZeneca Pharmaceuticals LP |
Substance Name | ANDEXANET ALFA |
Active Ingredient Strength | 200 mg/20mL |
NDC Exclude Flag | N |
Listing Certified Through | 2023-12-31 |
Marketing Start Date | 2022-07-12 |
NDC Exclude Flag | N |
Sample Package? | N |
NDC | Brand Name | Generic Name |
---|---|---|
0310-3200 | ANDEXXA | andexanet alfa |
69853-0101 | ANDEXXA | andexanet alfa |
69853-0102 | ANDEXXA | andexanet alfa |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ANDEXXA 86776730 5251742 Live/Registered |
Portola Pharmaceuticals, Inc. 2015-10-02 |