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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 200154


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NDA 200154 describes CISATRACURIUM BESYLATE PRESERVATIVE FREE, which is a drug marketed by Accord Hlthcare, Eugia Pharma, Fresenius Kabi Usa, Hengrui Pharma, Sandoz Inc, and Somerset Theraps Llc, and is included in six NDAs. It is available from six suppliers. Additional details are available on the CISATRACURIUM BESYLATE PRESERVATIVE FREE profile page.

The generic ingredient in CISATRACURIUM BESYLATE PRESERVATIVE FREE is cisatracurium besylate. There are nine drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the cisatracurium besylate profile page.
Summary for 200154
Pharmacology for NDA: 200154
Suppliers and Packaging for NDA: 200154
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CISATRACURIUM BESYLATE PRESERVATIVE FREE cisatracurium besylate INJECTABLE;INJECTION 200154 ANDA Sandoz Inc 0781-3150 0781-3150-95 10 BOX in 1 CARTON (0781-3150-95) / 1 VIAL in 1 BOX (0781-3150-75) / 5 mL in 1 VIAL
CISATRACURIUM BESYLATE PRESERVATIVE FREE cisatracurium besylate INJECTABLE;INJECTION 200154 ANDA Sandoz Inc 0781-3153 0781-3153-95 10 BOX in 1 CARTON (0781-3153-95) / 1 VIAL in 1 BOX (0781-3153-80) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML
Approval Date:Feb 3, 2012TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10MG BASE/ML
Approval Date:Feb 3, 2012TE:APRLD:No

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