MACLEODS PHARMS LTD Application 211427

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	EQ 50MG BASE	No	No
002	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	EQ 100MG BASE	No	No

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211427-001	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2025-01-15
A211427-002	DESVENLAFAXINE SUCCINATE	DESVENLAFAXINE SUCCINATE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2025-01-15

Application-product, TE code table
Application-product	TE code
A211427-001	AB
A211427-002	AB