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CYCLOBENZAPRINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: UNICHEM · Approved 2020-07-06

Drug application

FDA Application #

ANDA213324

Application type

Abbreviated New Drug Application (Generic)

Brand name

CYCLOBENZAPRINE HYDROCHLORIDE

Generic name

CYCLOBENZAPRINE HYDROCHLORIDE

Active ingredients

CYCLOBENZAPRINE HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

UNICHEM

Manufacturer

Unichem Pharmaceuticals (USA), Inc.

First approval

2020-07-06

Source

Authoritative

Drugs@FDA application overview

Machine

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