Last Updated: May 3, 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 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 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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