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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 212470

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NDA 212470 describes BUMETANIDE, which is a drug marketed by 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-one NDAs. It is available from thirty-four 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. Thirty-nine suppliers are listed for this compound. Additional details are available on the bumetanide profile page.

Summary for 212470

Tradename:	BUMETANIDE
Applicant:	Jubilant Generics
Ingredient:	bumetanide
Patents:	0

Medical Subject Heading (MeSH) Categories for 212470

Diuretics
Sodium Potassium Chloride Symporter Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Aug 5, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Aug 5, 2025	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Aug 5, 2025	TE:	AB	RLD:	No

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