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Last Updated: April 19, 2024

Details for New Drug Application (NDA): 206554


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NDA 206554 describes BENDAMUSTINE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Apotex, Breckenridge, Dr Reddys, Eugia Pharma, Kindos, Mylan Labs Ltd, Nang Kuang Pharm Co, Baxter Hlthcare Corp, and Hospira, and is included in eleven NDAs. It is available from six suppliers. Additional details are available on the BENDAMUSTINE HYDROCHLORIDE profile page.

The generic ingredient in BENDAMUSTINE HYDROCHLORIDE is bendamustine hydrochloride. There are twenty-three drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.
Summary for 206554
Tradename:BENDAMUSTINE HYDROCHLORIDE
Applicant:Nang Kuang Pharm Co
Ingredient:bendamustine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 206554

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;IV (INFUSION)Strength25MG/VIAL
Approval Date:Jun 7, 2023TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;IV (INFUSION)Strength100MG/VIAL
Approval Date:Jun 7, 2023TE:RLD:No

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