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Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078717

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NDA 078717 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 thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the rocuronium bromide profile page.
Summary for 078717
Tradename:ROCURONIUM BROMIDE
Applicant:Teva Pharms
Ingredient:rocuronium bromide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078717
Suppliers and Packaging for NDA: 078717
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROCURONIUM BROMIDE rocuronium bromide INJECTABLE;INJECTION 078717 ANDA Teva Parenteral Medicines, Inc. 0703-2394 N 0703-2394-03
ROCURONIUM BROMIDE rocuronium bromide INJECTABLE;INJECTION 078717 ANDA Teva Parenteral Medicines, Inc. 0703-2395 N 0703-2395-03

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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