Application 207418

Type: ANDA
Sponsor: ASCENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	15MG	No	No
002	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	30MG	No	No
003	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
004	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
005	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	20MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-917	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Camber Pharmaceuticals Inc	ANDA	Current
31722-917	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Camber Pharmaceuticals Inc	ANDA	Current
31722-917	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Camber Pharmaceuticals Inc	ANDA	Current
31722-918	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Camber Pharmaceuticals Inc	ANDA	Current
31722-918	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Camber Pharmaceuticals Inc	ANDA	Current
31722-918	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Camber Pharmaceuticals Inc	ANDA	Current
63629-1927	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1927	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1927	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1928	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1928	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1928	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1929	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1929	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1929	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1930	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1930	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1930	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8889	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8890	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-2126	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
72865-128	Oxycodone Hydrochloride	Oxycodone Hydrochloride	XLCare Pharmaceuticals, Inc	ANDA	Current
72865-128	Oxycodone Hydrochloride	Oxycodone Hydrochloride	XLCare Pharmaceuticals Inc	ANDA	Current
72865-128	Oxycodone Hydrochloride	Oxycodone Hydrochloride	XLCare Pharmaceuticals Inc	ANDA	Current
72865-129	Oxycodone Hydrochloride	Oxycodone Hydrochloride	XLCare Pharmaceuticals, Inc	ANDA	Current
72865-129	Oxycodone Hydrochloride	Oxycodone Hydrochloride	XLCare Pharmaceuticals Inc	ANDA	Current
72865-129	Oxycodone Hydrochloride	Oxycodone Hydrochloride	XLCare Pharmaceuticals Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76531	ORIG	2023-11-08