Details for New Drug Application (NDA): 216434

NDA 216434 describes BUMETANIDE, which is a drug marketed by Gland Pharma Ltd, Hospira, Lupin Ltd, MSN, Qilu Pharm Hainan, Sagent, Teva Parenteral, West-ward Pharms Int, Amneal Pharms Co, Appco, Heritage Pharma, Rising, Sandoz, Taro, Upsher Smith Labs, and Zydus Pharms, and is included in seventeen NDAs. It is available from twenty-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. Twenty-nine suppliers are listed for this compound. Additional details are available on the bumetanide profile page.

Summary for 216434

Tradename:	BUMETANIDE
Applicant:	Gland Pharma Ltd
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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