FDA.reportPublic FDA data

Application 217365

Type
ANDA
Sponsor
CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD.

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002PALBOCICLIB CAPSULESPALBOCICLIBCAPSULE125MGNoNo
003PALBOCICLIB CAPSULESPALBOCICLIBCAPSULE100MGNoNo

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbrancePALBOCICLIBU.S. Pharmaceuticals89a142d5-7e61-48bf-9e77-e2cd124c47922026-07-06Warnings, Adverse reactionsName fallback
generic name: PALBOCICLIB
IbrancePALBOCICLIBPfizer Laboratories Div Pfizer Incfecbdd7d-b729-41b5-9872-231b8fe104ce2026-07-02Warnings, Adverse reactionsName fallback
generic name: PALBOCICLIB
IbrancePALBOCICLIBPfizer Laboratories Div Pfizer Ince0e6412f-50b4-4fd4-9364-62818d121a072026-07-02Warnings, Adverse reactionsName fallback
generic name: PALBOCICLIB