FDA.reportPublic FDA data

Application 208971

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CINACALCET HYDROCHLORIDECINACALCET HYDROCHLORIDETABLET;ORALEQ 30MG BASENoNo
002CINACALCET HYDROCHLORIDECINACALCET HYDROCHLORIDETABLET;ORALEQ 60MG BASENoNo
003CINACALCET HYDROCHLORIDECINACALCET HYDROCHLORIDETABLET;ORALEQ 90MG BASENoNo

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 · 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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70710-1000CinacalcetCinacalcetZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1001CinacalcetCinacalcetZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1002CinacalcetCinacalcetZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1054CinacalcetCinacalcetCadila Healthcare LimitedANDACurrent
70771-1055CinacalcetCinacalcetCadila Healthcare LimitedANDACurrent
70771-1056CinacalcetCinacalcetCadila Healthcare LimitedANDACurrent