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Generated: April 27, 2017

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Details for New Drug Application (NDA): 019678

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NDA 019678 describes ENLON-PLUS, which is a drug marketed by Mylan Institutional and is included in two NDAs. It is available from one supplier. Additional details are available on the ENLON-PLUS profile page.

The generic ingredient in ENLON-PLUS is atropine sulfate; edrophonium chloride. There are twenty-two 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: 019678

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 019678

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
atropine sulfate; edrophonium chloride
INJECTABLE;INJECTION 019678 NDA Mylan Institutional LLC 67457-192 67457-192-05 10 AMPULE in 1 CARTON (67457-192-05) > 5 mL in 1 AMPULE (67457-192-00)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.14MG/ML;10MG/ML
Approval Date:Nov 6, 1991TE:RLD:Yes

Expired Orange Book Patents for NDA: 019678

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Institutional
atropine sulfate; edrophonium chloride
INJECTABLE;INJECTION019678-001Nov 6, 19914,952,586► Subscribe
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