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CYCLOBENZAPRINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: TWI PHARMS INC · Approved 2013-01-31

Drug application

FDA Application #

ANDA091281

Application type

Abbreviated New Drug Application (Generic)

Brand name

CYCLOBENZAPRINE HYDROCHLORIDE

Generic name

CYCLOBENZAPRINE HYDROCHLORIDE

Active ingredients

CYCLOBENZAPRINE HYDROCHLORIDE

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

TWI PHARMS INC

Manufacturer

Upsher-Smith Laboratories, LLC

First approval

2013-01-31

Source

Authoritative

Drugs@FDA application overview

Machine

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