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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 use. Initial U.S. Approval: 1995

Approved
Approval ID

2a68c2bc-3875-4782-820c-7dcad545ba9b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 17, 2022

Manufacturers
FDA

Piramal Healthcare UK Limited

DUNS: 345609965

Products 2

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 Code24584-1112
Application NumberANDA212432
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cisatracurium Besylate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 18, 2022
FDA Product Classification

INGREDIENTS (3)

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

Cisatracurium Besylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code24584-1111
Application NumberANDA212432
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cisatracurium Besylate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 18, 2022
FDA Product Classification

INGREDIENTS (3)

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

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Cisatracurium Besylate - FDA Drug Approval Details