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Details for New Drug Application (NDA): 088873

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NDA 088873 describes ENLON, which is a drug marketed by Mylan Institutional and is included in three NDAs. It is available from one supplier. Additional details are available on the ENLON profile page.

The generic ingredient in ENLON is atropine sulfate; edrophonium chloride. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the atropine sulfate; edrophonium chloride profile page.

Summary for NDA: 088873

Mylan Institutional
edrophonium chloride
Therapeutic Class:Antimyasthenic Agents

Pharmacology for NDA: 088873

Mechanism of ActionCholinesterase Inhibitors

Suppliers and Packaging for NDA: 088873

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
edrophonium chloride
INJECTABLE;INJECTION 088873 ANDA Mylan Institutional LLC 67457-190 67457-190-15 1 VIAL, GLASS in 1 CARTON (67457-190-15) > 15 mL in 1 VIAL, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Aug 6, 1985TE:RLD:Yes

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