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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 210111

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NDA 210111 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 two 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. Three suppliers are listed for this compound. Additional details are available on the pomalidomide profile page.

Summary for 210111

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

Pharmacology for NDA: 210111

Suppliers and Packaging for NDA: 210111

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
POMALIDOMIDE	pomalidomide	CAPSULE;ORAL	210111	ANDA	Breckenridge Pharmaceutical, Inc.	51991-342	51991-342-01	100 CAPSULE in 1 BOTTLE (51991-342-01)
POMALIDOMIDE	pomalidomide	CAPSULE;ORAL	210111	ANDA	Breckenridge Pharmaceutical, Inc.	51991-342	51991-342-21	21 CAPSULE in 1 BOTTLE, PLASTIC (51991-342-21)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	1MG
Approval Date:	Oct 30, 2020	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	2MG
Approval Date:	Oct 30, 2020	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	3MG
Approval Date:	Oct 30, 2020	TE:		RLD:	No

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