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Details for New Drug Application (NDA): 200154

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NDA 200154 describes CISATRACURIUM BESYLATE PRESERVATIVE FREE, which is a drug marketed by Sandoz Inc and Fresenius Kabi Usa and is included in two NDAs. It is available from two 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. Three suppliers are listed for this compound. Additional details are available on the cisatracurium besylate profile page.

Summary for NDA: 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

Summary for product number 001

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

Summary 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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