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CYCLOBENZAPRINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVAST LABS · Approved 2024-08-27

Drug application

FDA Application #
ANDA214732
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
NOVAST LABS
First approval
2024-08-27

Source

Authoritative
Drugs@FDA application overview
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