FDA Approved Products

Application #	Type	Sponsor	Product #	Drug Name	Form	Strength	Active Ingredient	Approval Date	Marketing Status	Reference Standard
208090	NDA	COLLEGIUM PHARM INC	001	XTAMPZA ER	CAPSULE, EXTENDED RELEASE;ORAL	9MG	OXYCODONE	2016-04-26	Prescription	No
			002	XTAMPZA ER	CAPSULE, EXTENDED RELEASE;ORAL	13.5MG	OXYCODONE	2016-04-26	Prescription	No
			003	XTAMPZA ER	CAPSULE, EXTENDED RELEASE;ORAL	18MG	OXYCODONE	2016-04-26	Prescription	No
			004	XTAMPZA ER	CAPSULE, EXTENDED RELEASE;ORAL	27MG	OXYCODONE	2016-04-26	Prescription	No
			005	XTAMPZA ER	CAPSULE, EXTENDED RELEASE;ORAL	36MG	OXYCODONE	2016-04-26	Prescription	Yes
203794	NDA	COLLEGIUM PHARM INC	001	NUCYNTA	SOLUTION;ORAL	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TAPENTADOL HYDROCHLORIDE	2012-10-15	Discontinued	No
200533	NDA	COLLEGIUM PHARM INC	001	NUCYNTA ER	TABLET, EXTENDED RELEASE;ORAL	EQ 50MG BASE	TAPENTADOL HYDROCHLORIDE	2011-08-25	Prescription	No
			002	NUCYNTA ER	TABLET, EXTENDED RELEASE;ORAL	EQ 100MG BASE	TAPENTADOL HYDROCHLORIDE	2011-08-25	Prescription	No
			003	NUCYNTA ER	TABLET, EXTENDED RELEASE;ORAL	EQ 150MG BASE	TAPENTADOL HYDROCHLORIDE	2011-08-25	Prescription	No
			004	NUCYNTA ER	TABLET, EXTENDED RELEASE;ORAL	EQ 200MG BASE	TAPENTADOL HYDROCHLORIDE	2011-08-25	Prescription	No
			005	NUCYNTA ER	TABLET, EXTENDED RELEASE;ORAL	EQ 250MG BASE	TAPENTADOL HYDROCHLORIDE	2011-08-25	Prescription	Yes
022304	NDA	COLLEGIUM PHARM INC	001	NUCYNTA	TABLET;ORAL	EQ 50MG BASE	TAPENTADOL HYDROCHLORIDE	2008-11-20	Prescription	No
			002	NUCYNTA	TABLET;ORAL	EQ 75MG BASE	TAPENTADOL HYDROCHLORIDE	2008-11-20	Prescription	No
			003	NUCYNTA	TABLET;ORAL	EQ 100MG BASE	TAPENTADOL HYDROCHLORIDE	2008-11-20	Prescription	Yes