CINQAIR
These highlights do not include all the information needed to use CINQAIR safely and effectively. See full prescribing information for CINQAIR.CINQAIR (reslizumab) injection, for intravenous useInitial U.S. Approval: 2016
Approved
Approval ID
053b9158-2a5b-48b9-bf47-5fa78a35ec33
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 29, 2020
Manufacturers
FDA
Teva Respiratory, LLC
DUNS: 176697907
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Reslizumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59310-610
Application NumberBLA761033
Product Classification
M
Marketing Category
C73585
G
Generic Name
Reslizumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 29, 2020
FDA Product Classification
INGREDIENTS (5)
RESLIZUMABActive
Quantity: 10 mg in 1 mL
Code: 35A26E427H
Classification: ACTIB
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT