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Details for New Drug Application (NDA): 206488

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NDA 206488 describes EXONDYS 51, which is a drug marketed by Sarepta Theraps Inc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the EXONDYS 51 profile page.

The generic ingredient in EXONDYS 51 is eteplirsen. One supplier is listed for this compound. Additional details are available on the eteplirsen profile page.

Summary for NDA: 206488

Tradename:
EXONDYS 51
Applicant:
Sarepta Theraps Inc
Ingredient:
eteplirsen
Patents:3

Pharmacology for NDA: 206488

Suppliers and Packaging for NDA: 206488

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EXONDYS 51
eteplirsen
SOLUTION;IV (INFUSION) 206488 NDA Sarepta Therapeutics, Inc. 60923-284 60923-284-10 1 VIAL, SINGLE-USE in 1 CARTON (60923-284-10) > 10 mL in 1 VIAL, SINGLE-USE
EXONDYS 51
eteplirsen
SOLUTION;IV (INFUSION) 206488 NDA Sarepta Therapeutics, Inc. 60923-363 60923-363-02 1 VIAL, SINGLE-USE in 1 CARTON (60923-363-02) > 2 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength100MG/2ML (50MG/ML)
Approval Date:Sep 19, 2016TE:RLD:Yes
Patent:8,486,907Patent Expiration:Jun 28, 2025Product Flag?Substance Flag?Delist Request?
Patent:9,018,368Patent Expiration:Jun 28, 2025Product Flag?YSubstance Flag?YDelist Request?
Patent:9,416,361Patent Expiration:May 4, 2021Product Flag?Substance Flag?YDelist Request?


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