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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Daiichi Sankyo
Cantor Fitzgerald
Fish and Richardson

Generated: November 22, 2017

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Details for New Drug Application (NDA): 078519

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NDA 078519 describes ROCURONIUM BROMIDE, which is a drug marketed by Aurobindo Pharma Ltd, Tamarang, Teva Pharms, Hospira, Fresenius Kabi Usa, Sagent Pharms, West Ward Pharm Corp, Sandoz Inc, and Mylan Institutional, 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 078519

Formulation / Manufacturing:see details

Pharmacology for NDA: 078519

Suppliers and Packaging for NDA: 078519

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
rocuronium bromide
INJECTABLE;INJECTION 078519 ANDA Hospira, Inc. 0409-9558 0409-9558-49 10 VIAL, MULTI-DOSE in 1 BOX (0409-9558-49) > 5 mL in 1 VIAL, MULTI-DOSE
rocuronium bromide
INJECTABLE;INJECTION 078519 ANDA Hospira, Inc. 0409-9558 0409-9558-50 10 VIAL, MULTI-DOSE in 1 BOX (0409-9558-50) > 10 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/5ML (10MG/ML)
Approval Date:Nov 26, 2008TE:APRLD:No

Summary 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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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Queensland Health
Chinese Patent Office
Express Scripts
Fish and Richardson
Federal Trade Commission

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