Details for New Drug Application (NDA): 216434

NDA 216434 describes BUMETANIDE, which is a drug marketed by Aspiro, Gland Pharma Ltd, Hospira, Lupin Ltd, MSN, Qilu Pharm Hainan, Sagent, Teva Parenteral, West-ward Pharms Int, Amneal Pharms Co, Appco, Heritage Pharma, Rising, Rubicon, Sandoz, Taro, Upsher Smith Labs, and Zydus Pharms, and is included in nineteen NDAs. It is available from twenty-eight 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 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

Complete Access Available with Subscription