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Generated: September 25, 2018

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Details for New Drug Application (NDA): 078519

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NDA 078519 describes ROCURONIUM BROMIDE, which is a drug marketed by Aurobindo Pharma Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Mylan Institutional, Sagent Pharms, Sandoz Inc, Tamarang, Teva Pharms, and West Ward Pharm Corp, and is included in ten NDAs. It is available from fifteen suppliers. Additional details are available on the ROCURONIUM BROMIDE profile page.

The generic ingredient in ROCURONIUM BROMIDE is rocuronium bromide. There are eleven drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the rocuronium bromide profile page.
Summary for 078519
Tradename:ROCURONIUM BROMIDE
Applicant:Hospira
Ingredient:rocuronium bromide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078519
Suppliers and Packaging for NDA: 078519
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROCURONIUM BROMIDE rocuronium bromide INJECTABLE;INJECTION 078519 ANDA Hospira, Inc. 0409-9558 0409-9558-49 10 VIAL, MULTI-DOSE in 1 BOX (0409-9558-49) > 5 mL in 1 VIAL, MULTI-DOSE
ROCURONIUM BROMIDE rocuronium bromide INJECTABLE;INJECTION 078519 ANDA Hospira, Inc. 0409-9558 0409-9558-50 10 VIAL, MULTI-DOSE in 1 BOX (0409-9558-50) > 10 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/5ML (10MG/ML)
Approval Date:Nov 26, 2008TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/10ML (10MG/ML)
Approval Date:Nov 26, 2008TE:APRLD:No

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