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FDA Drug information

Cisatracurium besylate

Read time: 1 mins
Marketing start date: 23 Dec 2024

Summary of product characteristics


Effective Time

20221017

Version

2

Spl Product Data Elements

cisatracurium besylate cisatracurium besylate CISATRACURIUM BESYLATE CISATRACURIUM BENZENESULFONIC ACID BENZYL ALCOHOL WATER

Application Number

ANDA213527

Brand Name

Cisatracurium besylate

Generic Name

cisatracurium besylate

Product Ndc

72785-0011

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container Label (20 mg/10 mL) NDC 72758-0011-1 Cisatracurium Besylate Injection, USP 20 mg/10 mL* (2 mg/mL) WARNING: Paralyzing Agent For Intravenous Injection 0.9% benzyl alcohol (added as a preservative) 10 mL Multiple-Dose Vial Rx only Carton Label (20 mg/10 mL) NDC 72758-0011-1 Cisatracurium Besylate Injection, USP 20 mg/10 mL* (2 mg/mL) WARNING: Paralyzing Agent For Intravenous Injection 0.9% benzyl alcohol (added as a preservative) 10 mL Multiple-Dose Vial Rx only Carton Label (20 mg/10 mL) NDC 72758-0011-6 Cisatracurium Besylate Injection, USP 20 mg/10 mL* (2 mg/mL) WARNING: Paralyzing Agent For Intravenous Injection 0.9% benzyl alcohol (added as a preservative) 10 x 10 mL Multiple-Dose Vial Rx only vial label carton for 1 vial carton of 10 vials

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