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ESZOPICLONE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN PHARMS INC · Approved 2013-03-26

Drug application

FDA Application #

ANDA091151

Application type

Abbreviated New Drug Application (Generic)

Brand name

ESZOPICLONE

Generic name

ESZOPICLONE

Active ingredients

ESZOPICLONE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

MYLAN PHARMS INC

Manufacturer

Mylan Pharmaceuticals Inc.

First approval

2013-03-26

Source

Authoritative

Drugs@FDA application overview

Machine

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