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Generated: April 26, 2017

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Details for New Drug Application (NDA): 078651

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NDA 078651 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 ten 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. Eleven suppliers are listed for this compound. Additional details are available on the rocuronium bromide profile page.

Summary for NDA: 078651


Pharmacology for NDA: 078651

Suppliers and Packaging for NDA: 078651

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
rocuronium bromide
INJECTABLE;INJECTION 078651 ANDA Fresenius Kabi USA, LLC 63323-426 63323-426-05 10 VIAL in 1 TRAY (63323-426-05) > 5 mL in 1 VIAL
rocuronium bromide
INJECTABLE;INJECTION 078651 ANDA Fresenius Kabi USA, LLC 63323-426 63323-426-10 10 VIAL in 1 TRAY (63323-426-10) > 10 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/5ML (10MG/ML)
Approval Date:Dec 29, 2008TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/10ML (10MG/ML)
Approval Date:Dec 29, 2008TE:APRLD:No

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