PharmaQ, Inc. Application 212722

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PIRFENIDONE	PIRFENIDONE	TABLET; ORAL	267MG	No	No
002	PIRFENIDONE	PIRFENIDONE	TABLET; ORAL	534MG	No	No
003	PIRFENIDONE	PIRFENIDONE	TABLET;ORAL	801MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42385-924	Pirfenidone	Pirfenidone	Laurus Labs Limited	ANDA	Current
42385-925	Pirfenidone	Pirfenidone	Laurus Labs Limited	ANDA	Current
42385-926	Pirfenidone	Pirfenidone	Laurus Labs Limited	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
64639	ORIG	2020-09-22