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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 074332


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NDA 074332 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 074332
Tradename:BUMETANIDE
Applicant:Hospira
Ingredient:bumetanide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 074332
Medical Subject Heading (MeSH) Categories for 074332
Suppliers and Packaging for NDA: 074332
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUMETANIDE bumetanide INJECTABLE;INJECTION 074332 ANDA Hospira, Inc. 0409-1412 0409-1412-04 10 VIAL in 1 BOX (0409-1412-04) / 4 mL in 1 VIAL (0409-1412-34)
BUMETANIDE bumetanide INJECTABLE;INJECTION 074332 ANDA Hospira, Inc. 0409-1412 0409-1412-10 10 VIAL, MULTI-DOSE in 1 BOX (0409-1412-10) / 10 mL in 1 VIAL, MULTI-DOSE (0409-1412-40)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.25MG/ML
Approval Date:Oct 31, 1994TE:APRLD:No

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