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Generated: January 17, 2019

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Details for New Drug Application (NDA): 079196

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NDA 079196 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, Upsher Smith Labs, and Zydus Pharms Usa Inc, and is included in ten 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. Twenty-one suppliers are listed for this compound. Additional details are available on the bumetanide profile page.
Summary for 079196
Applicant:West-ward Pharms Int
Formulation / Manufacturing:see details
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 West-Ward Pharmaceuticals Corp. 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 West-Ward Pharmaceuticals Corp. 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

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