Application 208055

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	TABLET;ORAL	20MG	No	No
002	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	TABLET;ORAL	40MG	No	No
003	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	TABLET;ORAL	80MG	No	No
004	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	TABLET;ORAL	120MG	No	No
005	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	TABLET;ORAL	60MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13668-464	Lurasidone Hydrochloride	Lurasidone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-464	Lurasidone Hydrochloride	Lurasidone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-465	Lurasidone Hydrochloride	Lurasidone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-465	Lurasidone Hydrochloride	Lurasidone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-466	Lurasidone Hydrochloride	Lurasidone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-466	Lurasidone Hydrochloride	Lurasidone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-467	Lurasidone Hydrochloride	Lurasidone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-467	Lurasidone Hydrochloride	Lurasidone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
55948	ORIG	2018-10-15