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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 213458


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NDA 213458 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 213458
Tradename:BUMETANIDE
Applicant:Taro
Ingredient:bumetanide
Patents:0
Pharmacology for NDA: 213458
Medical Subject Heading (MeSH) Categories for 213458
Suppliers and Packaging for NDA: 213458
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUMETANIDE bumetanide TABLET;ORAL 213458 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4223 51672-4223-1 100 TABLET in 1 BOTTLE (51672-4223-1)
BUMETANIDE bumetanide TABLET;ORAL 213458 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4224 51672-4224-1 100 TABLET in 1 BOTTLE (51672-4224-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Jul 24, 2023TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jul 24, 2023TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Jul 24, 2023TE:ABRLD:No

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