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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 022393

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NDA 022393 describes ISTODAX, which is a drug marketed by Bristol-myers and is included in one NDA. It is available from one supplier. Additional details are available on the ISTODAX profile page.

The generic ingredient in ISTODAX is romidepsin. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the romidepsin profile page.

Summary for 022393

Tradename:	ISTODAX
Applicant:	Bristol-myers
Ingredient:	romidepsin
Patents:	0

Suppliers and Packaging for NDA: 022393

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ISTODAX	romidepsin	POWDER;INTRAVENOUS	022393	NDA	Celgene Corporation	59572-984	59572-984-01	1 KIT in 1 CARTON (59572-984-01) * 2.2 mL in 1 VIAL, GLASS (59572-962-10) * 2.4 mL in 1 VIAL, GLASS (59572-973-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	10MG/VIAL
Approval Date:	Nov 5, 2009	TE:	AP	RLD:	Yes

Expired US Patents for NDA 022393

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol-myers	ISTODAX	romidepsin	POWDER;INTRAVENOUS	022393-001	Nov 5, 2009	4,977,138	⤷ Get Started Free
Bristol-myers	ISTODAX	romidepsin	POWDER;INTRAVENOUS	022393-001	Nov 5, 2009	7,611,724	⤷ Get Started Free
Bristol-myers	ISTODAX	romidepsin	POWDER;INTRAVENOUS	022393-001	Nov 5, 2009	7,608,280	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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