Home Applications 211846 Application 211846
Type ANDA
Sponsor SUN PHARM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 5MG No No 002 LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 10MG No No 003 LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 15MG No No 004 LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 25MG No No 005 LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 2.5MG No No 006 LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 20MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211846-001 LENALIDOMIDE LENALIDOMIDE 5MG CAPSULE / ORAL AB 2023-02-08 A211846-002 LENALIDOMIDE LENALIDOMIDE 10MG CAPSULE / ORAL AB 2023-02-08 A211846-003 LENALIDOMIDE LENALIDOMIDE 15MG CAPSULE / ORAL AB 2023-02-08 A211846-004 LENALIDOMIDE LENALIDOMIDE 25MG CAPSULE / ORAL AB 2023-02-08 A211846-005 LENALIDOMIDE LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 A211846-006 LENALIDOMIDE LENALIDOMIDE 20MG CAPSULE / ORAL AB 2023-03-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 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 · 138 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 A211846-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2023-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211846-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2023-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211846-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2023-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211846-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2023-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211846-005 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211846-006 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2023-03-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211846-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2023-02-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211846-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2023-02-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211846-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2023-02-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211846-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2023-02-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211846-005 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211846-006 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2023-03-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211846-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2023-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211846-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2023-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211846-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2023-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211846-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2023-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211846-005 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211846-006 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2023-03-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211846-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2023-02-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211846-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2023-02-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211846-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2023-02-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211846-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2023-02-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211846-005 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211846-006 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2023-03-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211846-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2023-02-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211846-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2023-02-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211846-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2023-02-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211846-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2023-02-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211846-005 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211846-006 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2023-03-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211846-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2023-02-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211846-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2023-02-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211846-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2023-02-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211846-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2023-02-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211846-005 LENALIDOMIDE 2.5MG CAPSULE / ORAL AB 2023-03-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211846-006 LENALIDOMIDE 20MG CAPSULE / ORAL AB 2023-03-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211846-001 LENALIDOMIDE 5MG CAPSULE / ORAL AB 2023-02-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211846-002 LENALIDOMIDE 10MG CAPSULE / ORAL AB 2023-02-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211846-003 LENALIDOMIDE 15MG CAPSULE / ORAL AB 2023-02-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211846-004 LENALIDOMIDE 25MG CAPSULE / ORAL AB 2023-02-08 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 138 observed states.
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 Lenalidomide LENALIDOMIDE Sun Pharmaceutical Industries, Inc. 84d9dec7-9250-4dbd-9a0d-23e75f111892 2024-12-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211846 application number: ANDA211846
Documents# Document, Submission type, Date table Document Submission type Date 76346 ORIG 2023-11-06