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Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091458

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NDA 091458 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 091458
Tradename:ROCURONIUM BROMIDE
Applicant:Sagent Pharms
Ingredient:rocuronium bromide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 091458
Suppliers and Packaging for NDA: 091458
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROCURONIUM BROMIDE rocuronium bromide INJECTABLE;INJECTION 091458 ANDA Sagent Pharmaceuticals 25021-662 25021-662-05 10 VIAL in 1 CARTON (25021-662-05) > 5 mL in 1 VIAL
ROCURONIUM BROMIDE rocuronium bromide INJECTABLE;INJECTION 091458 ANDA Sagent Pharmaceuticals 25021-662 25021-662-10 10 VIAL in 1 CARTON (25021-662-10) > 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/5ML (10MG/ML)
Approval Date:Jul 28, 2010TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/10ML (10MG/ML)
Approval Date:Jul 28, 2010TE:APRLD:No

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