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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079195

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NDA 079195 describes ROCURONIUM BROMIDE, which is a drug marketed by Aurobindo Pharma Ltd, Fresenius Kabi Usa, Hospira, Mylan Institutional, Sagent Pharms, Sandoz Inc, Tamarang, Teva Pharms, and West Ward Pharm Corp, and is included in nine NDAs. It is available from eleven 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. Twelve suppliers are listed for this compound. Additional details are available on the rocuronium bromide profile page.

Summary for 079195

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 079195

Suppliers and Packaging for NDA: 079195

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROCURONIUM BROMIDE rocuronium bromide INJECTABLE;INJECTION 079195 ANDA Sandoz Inc 0781-3220 0781-3220-92 10 VIAL, MULTI-DOSE in 1 CARTON (0781-3220-92) > 10 mL in 1 VIAL, MULTI-DOSE
ROCURONIUM BROMIDE rocuronium bromide INJECTABLE;INJECTION 079195 ANDA Sandoz Inc 0781-3220 0781-3220-75 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3220-75) > 5 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/10ML (10MG/ML)
Approval Date:Dec 5, 2008TE:APRLD:No


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