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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079199

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NDA 079199 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 fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the rocuronium bromide profile page.
Summary for 079199
Tradename:ROCURONIUM BROMIDE
Applicant:Mylan Institutional
Ingredient:rocuronium bromide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 079199
Suppliers and Packaging for NDA: 079199
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROCURONIUM BROMIDE rocuronium bromide INJECTABLE;INJECTION 079199 ANDA Mylan Institutional LLC 67457-228 N 67457-228-05
ROCURONIUM BROMIDE rocuronium bromide INJECTABLE;INJECTION 079199 ANDA Mylan Institutional LLC 67457-228 N 67457-228-10

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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