Details for New Drug Application (NDA): 074441

NDA 074441 describes BUMETANIDE, which is a drug marketed by Gland Pharma Ltd, Hospira, MSN, Sagent, Teva Parenteral, West-ward Pharms Int, Amneal Pharms Co, Heritage Pharma, Rising, Sandoz, Taro, Upsher Smith Labs, and Zydus Pharms, and is included in fourteen NDAs. It is available from twenty-three 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-six suppliers are listed for this compound. Additional details are available on the bumetanide profile page.

Summary for 074441

Tradename:	BUMETANIDE
Applicant:	Sagent
Ingredient:	bumetanide
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 074441

Physiological Effect

Increased Diuresis at Loop of Henle

Medical Subject Heading (MeSH) Categories for 074441

Diuretics

Sodium Potassium Chloride Symporter Inhibitors

Suppliers and Packaging for NDA: 074441

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUMETANIDE	bumetanide	INJECTABLE;INJECTION	074441	ANDA	Athenex Pharmaceutical Division, LLC.	70860-405	70860-405-04	10 VIAL, SINGLE-DOSE in 1 CARTON (70860-405-04) / 4 mL in 1 VIAL, SINGLE-DOSE
BUMETANIDE	bumetanide	INJECTABLE;INJECTION	074441	ANDA	Athenex Pharmaceutical Division, LLC.	70860-406	70860-406-10	10 VIAL, MULTI-DOSE in 1 CARTON (70860-406-10) / 10 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.25MG/ML
Approval Date:	Jan 27, 1995	TE:	AP	RLD:	No

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