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CYCLOBENZAPRINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: INVAGEN PHARMS · Approved 2010-07-23

Drug application

FDA Application #
ANDA090478
Application type
Abbreviated New Drug Application (Generic)
Brand name
CYCLOBENZAPRINE HYDROCHLORIDE
Generic name
CYCLOBENZAPRINE
Active ingredients
CYCLOBENZAPRINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
INVAGEN PHARMS
Manufacturer
EXELAN PHARMACEUTICALS, INC.
First approval
2010-07-23

Source

Authoritative
Drugs@FDA application overview
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