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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

887171ff-1f2f-4115-90a9-39d05cd5b955

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 15, 2022

Manufacturers
FDA

Civica, Inc.

DUNS: 081373942

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 Code72572-067
Application NumberANDA200154
Product Classification
M
Marketing Category
C73584
G
Generic Name
cisatracurium besylate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 13, 2022
FDA Product Classification

INGREDIENTS (3)

CISATRACURIUM BESYLATEActive
Quantity: 10 mg in 1 mL
Code: 80YS8O1MBS
Classification: ACTIM
BENZENESULFONIC ACIDInactive
Code: 685928Z18A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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cisatracurium besylate - FDA Drug Approval Details