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Details for New Drug Application (NDA): 019677

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NDA 019677 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 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: 019677

Tradename:
ENLON-PLUS
Applicant:
Mylan Institutional
Ingredient:
atropine sulfate; edrophonium chloride
Patents:0
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength0.14MG/ML;10MG/ML
Approval Date:Nov 6, 1991TE:RLD:No

Expired Orange Book Patents for NDA: 019677

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Institutional
ENLON-PLUS
atropine sulfate; edrophonium chloride
INJECTABLE;INJECTION019677-001Nov 6, 19914,952,586► subscribe
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