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ZOLPIDEM TARTRATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PH HEALTH · Approved 2017-09-11

Drug application

FDA Application #

ANDA204229

Application type

Abbreviated New Drug Application (Generic)

Brand name

ZOLPIDEM TARTRATE

Generic name

ZOLPIDEM TARTRATE SUBLINGUAL

Active ingredients

ZOLPIDEM TARTRATE

Dosage form

TABLET

Route

SUBLINGUAL

Marketing status

Prescription

Sponsor

PH HEALTH

Manufacturer

Par Health USA, LLC

First approval

2017-09-11

Source

Authoritative

Drugs@FDA application overview

Machine

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