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NUCYNTA

NDA · New Drug Application · Sponsor: COLLEGIUM PHARM INC · Approved 2008-11-20

Drug application

FDA Application #
NDA022304
Application type
New Drug Application
Brand name
NUCYNTA
Generic name
TAPENTADOL HYDROCHLORIDE
Active ingredients
TAPENTADOL HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
COLLEGIUM PHARM INC
Manufacturer
Hikma Pharmaceuticals USA Inc.
First approval
2008-11-20

Source

Authoritative
Drugs@FDA application overview
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