Home Applications 210249 Application 210249
Type ANDA
Sponsor EUGIA PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 POMALIDOMIDE POMALIDOMIDE CAPSULE;ORAL 1MG No No 002 POMALIDOMIDE POMALIDOMIDE CAPSULE;ORAL 2MG No No 003 POMALIDOMIDE POMALIDOMIDE CAPSULE;ORAL 3MG No No 004 POMALIDOMIDE POMALIDOMIDE CAPSULE;ORAL 4MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210249-001 POMALIDOMIDE POMALIDOMIDE 1MG CAPSULE / ORAL AB 2020-10-30 A210249-002 POMALIDOMIDE POMALIDOMIDE 2MG CAPSULE / ORAL AB 2020-10-30 A210249-003 POMALIDOMIDE POMALIDOMIDE 3MG CAPSULE / ORAL AB 2020-10-30 A210249-004 POMALIDOMIDE POMALIDOMIDE 4MG CAPSULE / ORAL AB 2020-10-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 144 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A210249-001 POMALIDOMIDE 1MG CAPSULE / ORAL AB 2020-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210249-002 POMALIDOMIDE 2MG CAPSULE / ORAL AB 2020-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210249-003 POMALIDOMIDE 3MG CAPSULE / ORAL AB 2020-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210249-004 POMALIDOMIDE 4MG CAPSULE / ORAL AB 2020-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210249-001 POMALIDOMIDE 1MG CAPSULE / ORAL 2020-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210249-002 POMALIDOMIDE 2MG CAPSULE / ORAL 2020-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210249-003 POMALIDOMIDE 3MG CAPSULE / ORAL 2020-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210249-004 POMALIDOMIDE 4MG CAPSULE / ORAL 2020-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210249-001 POMALIDOMIDE 1MG CAPSULE / ORAL 2020-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210249-002 POMALIDOMIDE 2MG CAPSULE / ORAL 2020-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210249-003 POMALIDOMIDE 3MG CAPSULE / ORAL 2020-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210249-004 POMALIDOMIDE 4MG CAPSULE / ORAL 2020-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210249-001 POMALIDOMIDE 1MG CAPSULE / ORAL 2020-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210249-002 POMALIDOMIDE 2MG CAPSULE / ORAL 2020-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210249-003 POMALIDOMIDE 3MG CAPSULE / ORAL 2020-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210249-004 POMALIDOMIDE 4MG CAPSULE / ORAL 2020-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210249-001 POMALIDOMIDE 1MG CAPSULE / ORAL 2020-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210249-002 POMALIDOMIDE 2MG CAPSULE / ORAL 2020-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210249-003 POMALIDOMIDE 3MG CAPSULE / ORAL 2020-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210249-004 POMALIDOMIDE 4MG CAPSULE / ORAL 2020-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210249-001 POMALIDOMIDE 1MG CAPSULE / ORAL 2020-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210249-002 POMALIDOMIDE 2MG CAPSULE / ORAL 2020-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210249-003 POMALIDOMIDE 3MG CAPSULE / ORAL 2020-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210249-004 POMALIDOMIDE 4MG CAPSULE / ORAL 2020-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210249-001 POMALIDOMIDE 1MG CAPSULE / ORAL 2020-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210249-002 POMALIDOMIDE 2MG CAPSULE / ORAL 2020-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210249-003 POMALIDOMIDE 3MG CAPSULE / ORAL 2020-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210249-004 POMALIDOMIDE 4MG CAPSULE / ORAL 2020-10-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210249-001 POMALIDOMIDE 1MG CAPSULE / ORAL 2020-10-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210249-002 POMALIDOMIDE 2MG CAPSULE / ORAL 2020-10-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210249-003 POMALIDOMIDE 3MG CAPSULE / ORAL 2020-10-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210249-004 POMALIDOMIDE 4MG CAPSULE / ORAL 2020-10-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210249-001 POMALIDOMIDE 1MG CAPSULE / ORAL 2020-10-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210249-002 POMALIDOMIDE 2MG CAPSULE / ORAL 2020-10-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210249-003 POMALIDOMIDE 3MG CAPSULE / ORAL 2020-10-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210249-004 POMALIDOMIDE 4MG CAPSULE / ORAL 2020-10-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210249-001 POMALIDOMIDE 1MG CAPSULE / ORAL 2020-10-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210249-002 POMALIDOMIDE 2MG CAPSULE / ORAL 2020-10-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210249-003 POMALIDOMIDE 3MG CAPSULE / ORAL 2020-10-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210249-004 POMALIDOMIDE 4MG CAPSULE / ORAL 2020-10-30 d06236e962d9…
Observed Orange Book normalized TE history# 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pomalidomide POMALIDOMIDE Aurobindo Pharma Limited 1539fbf9-8281-4c7b-827b-9f53b50d9042 2026-01-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210249 application number: ANDA210249
Documents# Document, Submission type, Date table Document Submission type Date 76285 ORIG 2023-11-03 65151 ORIG 2020-11-04