Application 207621

Type: NDA
Sponsor: PFIZER INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TROXYCA ER	NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	1.2MG;10MG	No	No
002	TROXYCA ER	NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	2.4MG;20MG	No	No
003	TROXYCA ER	NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	3.6MG;30MG	No	No
004	TROXYCA ER	NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	4.8MG;40MG	No	No
005	TROXYCA ER	NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	7.2MG;60MG	No	No
006	TROXYCA ER	NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	9.6MG;80MG	No	No

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48590	SUPPL	2017-05-31
46581	SUPPL	2016-12-29
46444	SUPPL	2016-12-21
46317	SUPPL	2016-12-20
46080	ORIG	2016-12-06
46079	ORIG	2016-12-06
45821	APPL	2016-11-04
45568	ORIG	2016-10-20
45450	SUPPL	2016-10-03
45369	ORIG	2016-09-21
45368	ORIG	2016-09-21
45047	ORIG	2016-08-19
45041	ORIG	2016-08-19