FDA.reportPublic FDA data

Application 213152

Type
ANDA
Sponsor
AIZANT DRUG RESEARCH SOLUTIONS PVT LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002PALBOCICLIBPALBOCICLIBCAPSULE;ORAL100MGNoNo
003PALBOCICLIBPALBOCICLIBCAPSULE;ORAL125MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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