Details for New Drug Application (NDA): 216434

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NDA 216434 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 216434

Tradename:	BUMETANIDE
Applicant:	Gland
Ingredient:	bumetanide
Patents:	0

Pharmacology for NDA: 216434

Physiological Effect

Increased Diuresis at Loop of Henle

Medical Subject Heading (MeSH) Categories for 216434

Diuretics

Sodium Potassium Chloride Symporter Inhibitors

Suppliers and Packaging for NDA: 216434

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUMETANIDE	bumetanide	INJECTABLE;INJECTION	216434	ANDA	Fresenius Kabi USA, LLC	65219-570	65219-570-04	10 VIAL, SINGLE-DOSE in 1 CARTON (65219-570-04) / 4 mL in 1 VIAL, SINGLE-DOSE (65219-570-01)
BUMETANIDE	bumetanide	INJECTABLE;INJECTION	216434	ANDA	Fresenius Kabi USA, LLC	65219-572	65219-572-10	10 VIAL, MULTI-DOSE in 1 CARTON (65219-572-10) / 10 mL in 1 VIAL, MULTI-DOSE (65219-572-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.25MG/ML
Approval Date:	May 26, 2022	TE:	AP	RLD:	No

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