FDA.reportPublic FDA data

Application 213234

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POMALIDOMIDEPOMALIDOMIDECAPSULE;ORAL1MGNoNo
002POMALIDOMIDEPOMALIDOMIDECAPSULE;ORAL2MGNoNo
003POMALIDOMIDEPOMALIDOMIDECAPSULE;ORAL3MGNoNo
004POMALIDOMIDEPOMALIDOMIDECAPSULE;ORAL4MGNoNo

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 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PomalidomidePOMALIDOMIDEApotex Corp.b1a1c713-d23b-5ede-1ae0-0bbba47221df2026-03-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pomalidomide
generic name: POMALIDOMIDE
PomalidomidePOMALIDOMIDEBreckenridge Pharmaceutical, Inc.41400b90-b64e-447b-90f3-1cad58050eba2026-03-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pomalidomide
generic name: POMALIDOMIDE
PomalidomidePOMALIDOMIDECamber Pharmaceuticals, Inc.52676691-e171-467c-ae55-b5dcc14062a42026-03-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pomalidomide
generic name: POMALIDOMIDE
PomalidomidePOMALIDOMIDEAurobindo Pharma Limited1539fbf9-8281-4c7b-827b-9f53b50d90422026-01-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pomalidomide
generic name: POMALIDOMIDE
PomalidomidePOMALIDOMIDENatco Pharma Limited0169dbda-53df-4cd9-b989-ff7544f1bdf52025-11-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pomalidomide
generic name: POMALIDOMIDE
PomalidomidePOMALIDOMIDETeva Pharmaceuticals, Inc.dee932c5-0c7c-45f0-b2bb-c027badee5372025-10-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pomalidomide
generic name: POMALIDOMIDE
PomalystPOMALIDOMIDECelgene Corporation2b25ef01-5c9e-11e1-b86c-0800200c9a662025-02-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: POMALIDOMIDE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69854ORIG2022-01-12