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Generated: April 26, 2017

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Details for New Drug Application (NDA): 020647

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NDA 020647 describes ELDEPRYL, which is a drug marketed by Somerset and is included in one NDA. It is available from one supplier. Additional details are available on the ELDEPRYL profile page.

The generic ingredient in ELDEPRYL is selegiline hydrochloride. There are sixteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the selegiline hydrochloride profile page.

Summary for NDA: 020647

Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020647

Suppliers and Packaging for NDA: 020647

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
selegiline hydrochloride
CAPSULE;ORAL 020647 NDA Mylan Specialty L.P. 49502-420 49502-420-60 60 CAPSULE in 1 BOTTLE (49502-420-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:May 15, 1996TE:ABRLD:Yes

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