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FDA Drug information

Cisatracurium besylate

Read time: 1 mins
Marketing start date: 27 Apr 2024
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Summary of product characteristics


Effective Time

20221105

Version

3

Spl Product Data Elements

cisatracurium besylate cisatracurium besylate CISATRACURIUM BESYLATE CISATRACURIUM BENZENESULFONIC ACID WATER cisatracurium besylate cisatracurium besylate CISATRACURIUM BESYLATE CISATRACURIUM BENZENESULFONIC ACID WATER

Application Number

ANDA212171

Brand Name

Cisatracurium besylate

Generic Name

cisatracurium besylate

Product Ndc

72785-0009

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

Principal Display Panel – Container Label (10 mg/5 mL) NDC 72785-0008-1 Cisatracurium Besylate Injection, USP 10 mg/5 mL* (2 mg/mL) WARNING: Paralyzing Agent For Intravenous Injection Preservative free 5 mL Single-Dose Vial Rx only Zydus Pharmaceuticals Principal Display Panel – Container Label (200 mg/20 mL) NDC 72785-0009-1 Cisatracurium Besylate Injection, USP 200 mg/20 mL* (10 mg/mL) WARNING: Paralyzing Agent For ICU use only. For Intravenous Injection Preservative free 20 mL Single-Dose Vial Rx only Zydus Pharmaceuticals Principal Display Panel – Carton Label (10 mg/5 mL) NDC 72785-0008-6 Cisatracurium Besylate Injection, USP 10 mg/5 mL* (2 mg/mL) WARNING: Paralyzing Agent For Intravenous Injection Preservative free 10 x 5 mL Single-Dose Vials Rx only Zydus Pharmaceuticals Principal Display Panel – Carton Label (200 mg/20 mL) NDC 72785-0009-6 Cisatracurium Besylate Injection, USP 200 mg/20 mL* (10 mg/mL) WARNING: Paralyzing Agent For ICU use only. For Intravenous Injection Preservative free 10 x 20 mL Single-Dose Vials Rx only Zydus Pharmaceuticals image10 image11 image12 image13

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