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NUCYNTA ER

NDA · New Drug Application · Sponsor: COLLEGIUM PHARM INC · Approved 2011-08-25

Drug application

FDA Application #

NDA200533

Application type

New Drug Application

Brand name

NUCYNTA ER

Generic name

TAPENTADOL HYDROCHLORIDE

Active ingredients

TAPENTADOL HYDROCHLORIDE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

COLLEGIUM PHARM INC

Manufacturer

Hikma Pharmaceuticals USA Inc.

First approval

2011-08-25

Source

Authoritative

Drugs@FDA application overview

Machine

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