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Last Updated: March 19, 2026

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. It is available from six suppliers. 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. Seven suppliers are listed for this compound. Additional details are available on the pomalidomide profile page.

Summary for 210164

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

Pharmacology for NDA: 210164

Suppliers and Packaging for NDA: 210164

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
POMALIDOMIDE	pomalidomide	CAPSULE;ORAL	210164	ANDA	Apotex Corp.	60505-4497	60505-4497-2	21 CAPSULE in 1 BOTTLE (60505-4497-2)
POMALIDOMIDE	pomalidomide	CAPSULE;ORAL	210164	ANDA	Apotex Corp.	60505-4498	60505-4498-2	21 CAPSULE in 1 BOTTLE (60505-4498-2)

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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