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ZALEPLON

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ORBION PHARMS · Approved 2009-09-17

Drug application

FDA Application #

ANDA090374

Application type

Abbreviated New Drug Application (Generic)

Brand name

ZALEPLON

Generic name

ZALEPLON

Active ingredients

ZALEPLON

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

ORBION PHARMS

Manufacturer

Bionpharma Inc.

First approval

2009-09-17

Source

Authoritative

Drugs@FDA application overview

Machine

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