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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 216539


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NDA 216539 describes CISATRACURIUM BESYLATE PRESERVATIVE FREE, which is a drug marketed by Accord Hlthcare, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly, Hengrui Pharma, Sandoz Inc, and Somerset Theraps Llc, and is included in seven 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. Fourteen suppliers are listed for this compound. Additional details are available on the cisatracurium besylate profile page.
Summary for 216539
Tradename:CISATRACURIUM BESYLATE PRESERVATIVE FREE
Applicant:Hainan Poly
Ingredient:cisatracurium besylate
Patents:0
Pharmacology for NDA: 216539
Physiological EffectNeuromuscular Nondepolarizing Blockade
Suppliers and Packaging for NDA: 216539
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CISATRACURIUM BESYLATE PRESERVATIVE FREE cisatracurium besylate INJECTABLE;INJECTION 216539 ANDA Slate Run Pharmaceuticals, LLC 70436-112 70436-112-82 10 VIAL, SINGLE-DOSE in 1 CARTON (70436-112-82) / 5 mL in 1 VIAL, SINGLE-DOSE
CISATRACURIUM BESYLATE PRESERVATIVE FREE cisatracurium besylate INJECTABLE;INJECTION 216539 ANDA Slate Run Pharmaceuticals, LLC 70436-114 70436-114-82 10 VIAL, SINGLE-DOSE in 1 CARTON (70436-114-82) / 20 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML
Approval Date:Aug 27, 2024TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 10MG BASE/ML
Approval Date:Aug 27, 2024TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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