You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 22, 2024

Details for New Drug Application (NDA): 079196


✉ Email this page to a colleague

« Back to Dashboard


NDA 079196 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 079196
Tradename:BUMETANIDE
Applicant:West-ward Pharms Int
Ingredient:bumetanide
Patents:0
Pharmacology for NDA: 079196
Medical Subject Heading (MeSH) Categories for 079196
Suppliers and Packaging for NDA: 079196
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUMETANIDE bumetanide INJECTABLE;INJECTION 079196 ANDA Hikma Pharmaceuticals USA Inc. 0641-6007 0641-6007-10 10 VIAL in 1 CARTON (0641-6007-10) / 10 mL in 1 VIAL (0641-6007-01)
BUMETANIDE bumetanide INJECTABLE;INJECTION 079196 ANDA Hikma Pharmaceuticals USA Inc. 0641-6008 0641-6008-10 10 VIAL in 1 CARTON (0641-6008-10) / 4 mL in 1 VIAL (0641-6008-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.25MG/ML
Approval Date:Apr 30, 2008TE:APRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.