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Last Updated: December 23, 2024

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. Three 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:RXDosage:POWDER;INTRAVENOUSStrength10MG/VIAL
Approval Date:Nov 5, 2009TE:APRLD:Yes

Expired US Patents for NDA 022393

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol-myers ISTODAX romidepsin POWDER;INTRAVENOUS 022393-001 Nov 5, 2009 ⤷  Subscribe ⤷  Subscribe
Bristol-myers ISTODAX romidepsin POWDER;INTRAVENOUS 022393-001 Nov 5, 2009 ⤷  Subscribe ⤷  Subscribe
Bristol-myers ISTODAX romidepsin POWDER;INTRAVENOUS 022393-001 Nov 5, 2009 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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