Application 210661

Type: NDA
Sponsor: APOTEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PEMETREXED	PEMETREXED	INJECTABLE;INJECTION	100MG	No	No
002	PEMETREXED	PEMETREXED	INJECTABLE;INJECTION	500MG	No	No

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83673	SUPPL	2025-10-06
83666	SUPPL	2025-10-06
82619	SUPPL	2025-06-20
82618	SUPPL	2025-06-20
81626	ORIG	2025-03-18
80483	SUPPL	2024-12-03
80477	SUPPL	2024-12-03
80506	ORIG	2024-06-12
53528	ORIG	2018-03-29