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Cisatracurium Besylate

These highlights do not include all the information needed to use CISATRACURIUM BESYLATE INJECTION safely and effectively. See full prescribing information for CISATRACURIUM BESYLATE INJECTION.CISATRACURIUM BESYLATE injection, for intravenous useInitial U.S. Approval: 1995

Approved
Approval ID

23daa1f8-2a07-449d-97a6-11efdb0b9836

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 7, 2023

Manufacturers
FDA

Somerset Therapeutics, LLC

DUNS: 079947873

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Cisatracurium Besylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70069-161
Application NumberANDA209132
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cisatracurium Besylate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 7, 2023
FDA Product Classification

INGREDIENTS (4)

CISATRACURIUM BESYLATEActive
Quantity: 2 mg in 1 mL
Code: 80YS8O1MBS
Classification: ACTIM
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
BENZENESULFONIC ACIDInactive
Code: 685928Z18A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Cisatracurium Besylate - FDA Drug Approval Details