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Last Updated: October 31, 2024

Details for New Drug Application (NDA): 091115


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NDA 091115 describes ROCURONIUM BROMIDE, which is a drug marketed by Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Meitheal, Mylan Institutional, Norvium Bioscience, Piramal Critical, Prinston Inc, Sagent Pharms Inc, Sandoz, Shandong, Steriscience, Tamarang, Teva Pharms, and West Ward Pharm Corp, and is included in eighteen NDAs. It is available from twenty-two 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. Twenty-two suppliers are listed for this compound. Additional details are available on the rocuronium bromide profile page.
Summary for 091115
Tradename:ROCURONIUM BROMIDE
Applicant:Tamarang
Ingredient:rocuronium bromide
Patents:0
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 XGen Pharmaceuticals DJB, 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 XGen Pharmaceuticals DJB, 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

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