Last Updated: June 19, 2026

Details for New Drug Application (NDA): 220427

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NDA 220427 describes BUMETANIDE, which is a drug marketed by Anthea Pharma, 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-seven 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-one suppliers are listed for this compound. Additional details are available on the bumetanide profile page.

Summary for 220427

Tradename:	BUMETANIDE
Applicant:	Anthea Pharma
Ingredient:	bumetanide
Patents:	0

Pharmacology for NDA: 220427

Physiological Effect	Increased Diuresis at Loop of Henle

Medical Subject Heading (MeSH) Categories for 220427

Diuretics
Sodium Potassium Chloride Symporter Inhibitors

Suppliers and Packaging for NDA: 220427

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUMETANIDE	bumetanide	INJECTABLE;INJECTION	220427	ANDA	Anthea Pharma Private Limited	83854-007	83854-007-10	10 VIAL in 1 CARTON (83854-007-10) / 4 mL in 1 VIAL (83854-007-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.25MG/ML
Approval Date:	Feb 26, 2026	TE:	AP	RLD:	No

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