FDA.reportPublic FDA data

Application 090539

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CINACALCET HYDROCHLORIDECINACALCET HYDROCHLORIDETABLET; ORAL90MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 ยท 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SensiparCINACALCET HYDROCHLORIDEAmgen Inc45028573-13c4-4c8b-ae62-6c75bba97c812025-12-07Warnings, Adverse reactionsName fallback
generic name: CINACALCET HYDROCHLORIDE
Cinacalcet HydrochlorideCINACALCETAmneal Pharmaceuticals LLC28262843-b0a8-4ca7-8b92-41b7f0e896b42021-08-24Warnings, Adverse reactionsName fallback
brand name: Cinacalcet Hydrochloride

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31479ORIG2010-04-28