Last Updated: November 8, 2026

Details for New Drug Application (NDA): 215362

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NDA 215362 describes BUMETANIDE, which is a drug marketed by Adaptis, Aspiro, Gland, Hospira, Lupin, MSN, Qilu Pharm Hainan, Sagent, Teva Parenteral, West-ward Pharms Int, Amneal Pharms Co, Appco, Heritage Pharma, Jubilant Generics, Mankind Pharma, Rising, Rubicon Research, Sandoz, Taro, Upsher Smith Labs, and Zydus Pharms, and is included in twenty-three NDAs. It is available from thirty-six suppliers. Additional details are available on the BUMETANIDE profile page.

The generic ingredient in BUMETANIDE is bumetanide. There is one drug master file entry for this compound. Forty suppliers are listed for this compound. Additional details are available on the bumetanide profile page.
Summary for 215362
Tradename:BUMETANIDE
Applicant:Msn
Ingredient:bumetanide
Patents:0
Pharmacology for NDA: 215362
Physiological EffectIncreased Diuresis at Loop of Henle
Medical Subject Heading (MeSH) Categories for 215362
Diuretics
Sodium Potassium Chloride Symporter Inhibitors
Suppliers and Packaging for NDA: 215362
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUMETANIDE bumetanide TABLET;ORAL 215362 ANDA Novadoz Pharmaceuticals LLC 72205-056 72205-056-91 100 TABLET in 1 BOTTLE (72205-056-91)
BUMETANIDE bumetanide TABLET;ORAL 215362 ANDA Novadoz Pharmaceuticals LLC 72205-057 72205-057-05 500 TABLET in 1 BOTTLE (72205-057-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Feb 5, 2026TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Feb 5, 2026TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Feb 5, 2026TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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