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ZOLPIDEM TARTRATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: BRECKENRIDGE · Approved 2020-06-04

Drug application

FDA Application #

ANDA213592

Application type

Abbreviated New Drug Application (Generic)

Brand name

ZOLPIDEM TARTRATE

Generic name

ZOLPIDEM TARTRATE

Active ingredients

ZOLPIDEM TARTRATE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

BRECKENRIDGE

Manufacturer

Breckenridge Pharmaceutical, Inc.

First approval

2020-06-04

Source

Authoritative

Drugs@FDA application overview

Machine

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