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Generated: April 19, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203182

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NDA 203182 describes CISATRACURIUM BESYLATE PRESERVATIVE FREE, which is a drug marketed by Accord Hlthcare, Fresenius Kabi Usa, Jiangsu Hengrui Med, Sandoz Inc, and Somerset Theraps Llc, and is included in five NDAs. It is available from five 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. Six suppliers are listed for this compound. Additional details are available on the cisatracurium besylate profile page.
Summary for 203182
Pharmacology for NDA: 203182
Suppliers and Packaging for NDA: 203182
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CISATRACURIUM BESYLATE PRESERVATIVE FREE cisatracurium besylate INJECTABLE;INJECTION 203182 ANDA Fresenius Kabi USA, LLC 63323-416 63323-416-05 10 VIAL in 1 CARTON (63323-416-05) > 5 mL in 1 VIAL
CISATRACURIUM BESYLATE PRESERVATIVE FREE cisatracurium besylate INJECTABLE;INJECTION 203182 ANDA Fresenius Kabi USA, LLC 63323-418 63323-418-20 10 VIAL in 1 CARTON (63323-418-20) > 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML
Approval Date:Feb 26, 2015TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10MG BASE/ML
Approval Date:Feb 26, 2015TE:APRLD:No

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