➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
Express Scripts

Last Updated: July 30, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091115

Email this page to a colleague

« Back to Dashboard

NDA 091115 describes ROCURONIUM BROMIDE, which is a drug marketed by Aurobindo Pharma Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Mylan Institutional, Piramal Critical, Sagent Pharms Inc, Sandoz Inc, Tamarang, Teva Pharms, and West Ward Pharm Corp, and is included in eleven 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 091115
Ingredient:rocuronium bromide
Formulation / Manufacturing:see details
Pharmacology for NDA: 091115
Suppliers and Packaging for NDA: 091115
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROCURONIUM BROMIDE rocuronium bromide INJECTABLE;INJECTION 091115 ANDA X-GEN Pharmaceuticals, Inc. 39822-4200 39822-4200-2 10 VIAL in 1 CARTON (39822-4200-2) > 5 mL in 1 VIAL (39822-4200-1)
ROCURONIUM BROMIDE rocuronium bromide INJECTABLE;INJECTION 091115 ANDA X-GEN Pharmaceuticals, Inc. 39822-4200 39822-4200-6 10 VIAL in 1 CARTON (39822-4200-6) > 10 mL in 1 VIAL (39822-4200-5)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/5ML (10MG/ML)
Approval Date:Aug 27, 2012TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/10ML (10MG/ML)
Approval Date:Aug 27, 2012TE:APRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.