Last Updated: May 3, 2026

Details for New Drug Application (NDA): 217153


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NDA 217153 describes BUMETANIDE, which is a drug marketed by Anthea Pharma, Aspiro, Gland, Hospira, Lupin Ltd, 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 are six drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the bumetanide profile page.
Summary for 217153
Tradename:BUMETANIDE
Applicant:Lupin Ltd
Ingredient:bumetanide
Patents:0
Pharmacology for NDA: 217153
Physiological EffectIncreased Diuresis at Loop of Henle
Medical Subject Heading (MeSH) Categories for 217153
Diuretics
Sodium Potassium Chloride Symporter Inhibitors
Suppliers and Packaging for NDA: 217153
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUMETANIDE bumetanide INJECTABLE;INJECTION 217153 ANDA Lupin Pharmaceuticals, Inc. 70748-323 70748-323-10 10 VIAL in 1 CARTON (70748-323-10) / 4 mL in 1 VIAL
BUMETANIDE bumetanide INJECTABLE;INJECTION 217153 ANDA Lupin Pharmaceuticals, Inc. 70748-323 70748-323-11 10 VIAL in 1 CARTON (70748-323-11) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.25MG/ML
Approval Date:Sep 17, 2024TE:APRLD:No

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Preferred Citation:

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