NDC 60923-227

AMONDYS 45

Casimersen

AMONDYS 45 is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Sarepta Therapeutics, Inc.. The primary component is Casimersen.

Product ID60923-227_7d131a39-559d-478b-b221-4f6f4bc91f18
NDC60923-227
Product TypeHuman Prescription Drug
Proprietary NameAMONDYS 45
Generic NameCasimersen
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2021-02-25
Marketing CategoryNDA /
Application NumberNDA213026
Labeler NameSarepta Therapeutics, Inc.
Substance NameCASIMERSEN
Active Ingredient Strength50 mg/mL
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 60923-227-02

1 VIAL, SINGLE-USE in 1 CARTON (60923-227-02) > 2 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2021-02-25
NDC Exclude FlagN
Sample Package?N

Drug Details


Trademark Results [AMONDYS 45]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AMONDYS 45
AMONDYS 45
90135119 not registered Live/Pending
Sarepta Therapeutics, Inc.
2020-08-25

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