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Generated: November 18, 2018

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Details for New Drug Application (NDA): 204960

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NDA 204960 describes CISATRACURIUM BESYLATE PRESERVATIVE FREE, which is a drug marketed by Accord Hlthcare, Fresenius Kabi Usa, Jiangsu Hengrui Med, and Sandoz Inc, and is included in four NDAs. It is available from four 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. Five suppliers are listed for this compound. Additional details are available on the cisatracurium besylate profile page.
Summary for 204960
Pharmacology for NDA: 204960
Suppliers and Packaging for NDA: 204960
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CISATRACURIUM BESYLATE PRESERVATIVE FREE cisatracurium besylate INJECTABLE;INJECTION 204960 ANDA Teva Parenteral Medicines, Inc. 0703-2033 0703-2033-03 10 CARTON in 1 BOX (0703-2033-03) > 1 VIAL in 1 CARTON > 5 mL in 1 VIAL
CISATRACURIUM BESYLATE PRESERVATIVE FREE cisatracurium besylate INJECTABLE;INJECTION 204960 ANDA Teva Parenteral Medicines, Inc. 0703-2045 0703-2045-03 10 CARTON in 1 BOX (0703-2045-03) > 1 VIAL in 1 CARTON > 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML
Approval Date:Jan 27, 2017TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10MG BASE/ML
Approval Date:Sep 19, 2017TE:APRLD:No

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