FDA.reportPublic FDA data

Application 213091

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PALBOCICLIBPALBOCICLIBCAPSULE;ORAL75MGNoNo
002PALBOCICLIBPALBOCICLIBCAPSULE;ORAL100MGNoNo
003PALBOCICLIBPALBOCICLIBCAPSULE;ORAL125MGNoNo

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 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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68524ORIG2021-09-02