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FDA Approval

CINQAIR

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Teva Respiratory, LLC
DUNS: 176697907
Effective Date
June 29, 2020
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Reslizumab(10 mg in 1 mL)

Products1

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

CINQAIR

Product Details

NDC Product Code
59310-610
Application Number
BLA761033
Marketing Category
BLA (C73585)
Route of Administration
INTRAVENOUS
Effective Date
June 29, 2020
Code: 35A26E427HClass: ACTIBQuantity: 10 mg in 1 mL
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
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