NDC 0310-3200

ANDEXXA

Andexanet Alfa

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 ID0310-3200_2d9d90a6-63e6-46ef-96ff-dd6519ae7b6c
NDC0310-3200
Product TypeHuman Prescription Drug
Proprietary NameANDEXXA
Generic NameAndexanet Alfa
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2022-07-12
Marketing CategoryBLA /
Application NumberBLA125586
Labeler NameAstraZeneca Pharmaceuticals LP
Substance NameANDEXANET ALFA
Active Ingredient Strength200 mg/20mL
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0310-3200-04

4 VIAL, SINGLE-USE in 1 CARTON (0310-3200-04) > 20 mL in 1 VIAL, SINGLE-USE (0310-3200-01)
Marketing Start Date2022-07-12
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "ANDEXXA" or generic name "Andexanet Alfa"

NDCBrand NameGeneric Name
0310-3200ANDEXXAandexanet alfa
69853-0101ANDEXXAandexanet alfa
69853-0102ANDEXXAandexanet alfa

Trademark Results [ANDEXXA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ANDEXXA
ANDEXXA
86776730 5251742 Live/Registered
Portola Pharmaceuticals, Inc.
2015-10-02

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