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Last Updated: December 28, 2024

Details for New Drug Application (NDA): 210164

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NDA 210164 describes POMALIDOMIDE, which is a drug marketed by Apotex, Breckenridge, Eugia Pharma, Hetero Labs Ltd V, Mylan, and Teva Pharms Usa, and is included in six NDAs. Additional details are available on the POMALIDOMIDE profile page.

The generic ingredient in POMALIDOMIDE is pomalidomide. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pomalidomide profile page.

Summary for 210164

Tradename:	POMALIDOMIDE
Applicant:	Apotex
Ingredient:	pomalidomide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	1MG
Approval Date:	Jun 11, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	2MG
Approval Date:	Jun 11, 2024	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	3MG
Approval Date:	Jun 11, 2024	TE:	AB	RLD:	No

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