NDC 73657-020

Pepaxto

Melphalan Flufenamide

Pepaxto is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Oncopeptides, Ab. The primary component is Melphalan Flufenamide.

Product ID73657-020_779bf257-f198-4c8e-8ddf-87d3c14d8c77
NDC73657-020
Product TypeHuman Prescription Drug
Proprietary NamePepaxto
Generic NameMelphalan Flufenamide
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2021-02-26
Marketing CategoryNDA /
Application NumberNDA214383
Labeler NameOncopeptides, AB
Substance NameMELPHALAN FLUFENAMIDE
Active Ingredient Strength20 mg/50mL
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 73657-020-01

1 VIAL, GLASS in 1 CARTON (73657-020-01) > 50 mL in 1 VIAL, GLASS
Marketing Start Date2021-02-26
NDC Exclude FlagN
Sample Package?N

Drug Details


Trademark Results [Pepaxto]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PEPAXTO
PEPAXTO
79275014 not registered Live/Pending
Oncopeptides AB
2019-11-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.