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Last Updated: September 27, 2021

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Details for New Drug Application (NDA): 208574

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NDA 208574 describes ROMIDEPSIN, which is a drug marketed by Teva Pharms Usa Inc and is included in one NDA. It is available from one supplier. Additional details are available on the ROMIDEPSIN profile page.

The generic ingredient in ROMIDEPSIN 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 208574
Applicant:Teva Pharms Usa Inc
Suppliers and Packaging for NDA: 208574
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROMIDEPSIN romidepsin SOLUTION;INTRAVENOUS 208574 NDA Teva Parenteral Medicines, Inc. 0703-4004 0703-4004-01 1 VIAL in 1 CARTON (0703-4004-01) > 5.5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrength10MG/2ML (5MG/ML)
Approval Date:Mar 13, 2020TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength27.5MG/5.5ML (5MG/ML)
Approval Date:Mar 13, 2020TE:RLD:Yes

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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