Home Applications 210236 Application 210236
Type ANDA
Sponsor HETERO LABS LTD V 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 A210236-001 POMALIDOMIDE POMALIDOMIDE 1MG CAPSULE / ORAL AB 2024-09-26 A210236-002 POMALIDOMIDE POMALIDOMIDE 2MG CAPSULE / ORAL AB 2024-09-26 A210236-003 POMALIDOMIDE POMALIDOMIDE 3MG CAPSULE / ORAL AB 2024-09-26 A210236-004 POMALIDOMIDE POMALIDOMIDE 4MG CAPSULE / ORAL AB 2024-09-26
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.
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 A210236-001 POMALIDOMIDE 1MG CAPSULE / ORAL AB 2024-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210236-002 POMALIDOMIDE 2MG CAPSULE / ORAL AB 2024-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210236-003 POMALIDOMIDE 3MG CAPSULE / ORAL AB 2024-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210236-004 POMALIDOMIDE 4MG CAPSULE / ORAL AB 2024-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210236-001 POMALIDOMIDE 1MG CAPSULE / ORAL 2024-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210236-002 POMALIDOMIDE 2MG CAPSULE / ORAL 2024-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210236-003 POMALIDOMIDE 3MG CAPSULE / ORAL 2024-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210236-004 POMALIDOMIDE 4MG CAPSULE / ORAL 2024-09-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210236-001 POMALIDOMIDE 1MG CAPSULE / ORAL 2024-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210236-002 POMALIDOMIDE 2MG CAPSULE / ORAL 2024-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210236-003 POMALIDOMIDE 3MG CAPSULE / ORAL 2024-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210236-004 POMALIDOMIDE 4MG CAPSULE / ORAL 2024-09-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210236-001 POMALIDOMIDE 1MG CAPSULE / ORAL AB 2024-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210236-002 POMALIDOMIDE 2MG CAPSULE / ORAL AB 2024-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210236-003 POMALIDOMIDE 3MG CAPSULE / ORAL AB 2024-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210236-004 POMALIDOMIDE 4MG CAPSULE / ORAL AB 2024-09-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210236-001 POMALIDOMIDE 1MG CAPSULE / ORAL AB 2024-09-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210236-002 POMALIDOMIDE 2MG CAPSULE / ORAL AB 2024-09-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210236-003 POMALIDOMIDE 3MG CAPSULE / ORAL AB 2024-09-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210236-004 POMALIDOMIDE 4MG CAPSULE / ORAL AB 2024-09-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210236-001 POMALIDOMIDE 1MG CAPSULE / ORAL AB 2024-09-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210236-002 POMALIDOMIDE 2MG CAPSULE / ORAL AB 2024-09-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210236-003 POMALIDOMIDE 3MG CAPSULE / ORAL AB 2024-09-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210236-004 POMALIDOMIDE 4MG CAPSULE / ORAL AB 2024-09-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210236-001 POMALIDOMIDE 1MG CAPSULE / ORAL AB 2024-09-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210236-002 POMALIDOMIDE 2MG CAPSULE / ORAL AB 2024-09-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210236-003 POMALIDOMIDE 3MG CAPSULE / ORAL AB 2024-09-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210236-004 POMALIDOMIDE 4MG CAPSULE / ORAL AB 2024-09-26 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210236-001 POMALIDOMIDE 1MG CAPSULE / ORAL AB 2024-09-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210236-002 POMALIDOMIDE 2MG CAPSULE / ORAL AB 2024-09-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210236-003 POMALIDOMIDE 3MG CAPSULE / ORAL AB 2024-09-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210236-004 POMALIDOMIDE 4MG CAPSULE / ORAL AB 2024-09-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210236-001 POMALIDOMIDE 1MG CAPSULE / ORAL AB 2024-09-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210236-002 POMALIDOMIDE 2MG CAPSULE / ORAL AB 2024-09-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210236-003 POMALIDOMIDE 3MG CAPSULE / ORAL AB 2024-09-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210236-004 POMALIDOMIDE 4MG CAPSULE / ORAL AB 2024-09-26 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210236-001 POMALIDOMIDE 1MG CAPSULE / ORAL AB 2024-09-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210236-002 POMALIDOMIDE 2MG CAPSULE / ORAL AB 2024-09-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210236-003 POMALIDOMIDE 3MG CAPSULE / ORAL AB 2024-09-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210236-004 POMALIDOMIDE 4MG CAPSULE / ORAL AB 2024-09-26 a50c72e98297…
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 Camber Pharmaceuticals, Inc. 52676691-e171-467c-ae55-b5dcc14062a4 2026-03-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210236 application number: ANDA210236