FDA.reportPublic FDA data

Application 761033

Type
BLA
Sponsor
TEVA RESPIRATORY LLC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761033Cinqairreslizumab351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CINQAIRRESLIZUMABINJECTABLE;INJECTION100MG/10MLNoNo

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CINQAIRRESLIZUMABTeva Respiratory, LLC053b9158-2a5b-48b9-bf47-5fa78a35ec332020-02-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761033
ndc (product): 59310-610

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59310-610CINQAIRReslizumabTeva Respiratory, LLCBLACurrent
59310-610CINQAIRReslizumabTeva Respiratory, LLCBLACurrent
59310-610CINQAIRReslizumabTeva Respiratory, LLCBLACurrent
59310-610CINQAIRReslizumabTeva Respiratory, LLCBLACurrent
59310-610CINQAIRReslizumabTeva Respiratory, LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57253SUPPL2019-01-18
57172SUPPL2019-01-10
44978ORIG2016-05-05
23056ORIG2016-05-05
20001ORIG2016-03-29
10661ORIG2016-03-29
51639ORIG1900-01-01
51638ORIG1900-01-01
51637ORIG1900-01-01