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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209724

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NDA 209724 describes BUMETANIDE, which is a drug marketed by Athenex Inc, Hospira, Teva Parenteral, West-ward Pharms Int, Amneal Pharms Co, Ivax Sub Teva Pharms, Sandoz, and Upsher-smith Labs, and is included in nine NDAs. It is available from eighteen suppliers. Additional details are available on the BUMETANIDE profile page.

The generic ingredient in BUMETANIDE is bumetanide. There are five drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the bumetanide profile page.
Summary for 209724
Tradename:BUMETANIDE
Applicant:Amneal Pharms Co
Ingredient:bumetanide
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 209724
Medical Subject Heading (MeSH) Categories for 209724
Suppliers and Packaging for NDA: 209724
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUMETANIDE bumetanide TABLET;ORAL 209724 ANDA NuCare Pharmaceuticals,Inc. 68071-4330 N 68071-4330-3
BUMETANIDE bumetanide TABLET;ORAL 209724 ANDA NuCare Pharmaceuticals,Inc. 68071-4330 N 68071-4330-9

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Oct 18, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Oct 18, 2017TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Oct 18, 2017TE:ABRLD:No

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