Home Applications 021588 Application 021588
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GLEEVEC IMATINIB MESYLATE TABLET;ORAL EQ 100MG BASE Yes No 002 GLEEVEC IMATINIB MESYLATE TABLET;ORAL EQ 400MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021588-001 GLEEVEC IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 N021588-002 GLEEVEC IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB RLD 2003-04-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 82 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 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Observed Orange Book patent history# Patent history page 1 of 3 · 96 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021588-001 6958335*PED 2022-06-19 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021588-002 6958335*PED 2022-06-19 Pediatric extension 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021588-001 6958335*PED 2022-06-19 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021588-002 6958335*PED 2022-06-19 Pediatric extension 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021588-001 6958335*PED 2022-06-19 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021588-002 6958335*PED 2022-06-19 Pediatric extension 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021588-001 RE43932*PED 2019-01-16 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021588-001 6894051 2019-05-23 U-649 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021588-001 6894051*PED 2019-11-23 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021588-001 6958335 2021-12-19 U-1883 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021588-001 6958335 2021-12-19 U-791 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021588-001 6958335*PED 2022-06-19 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021588-002 RE43932*PED 2019-01-16 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021588-002 6894051 2019-05-23 U-649 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021588-002 6894051*PED 2019-11-23 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021588-002 6958335 2021-12-19 U-791 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021588-002 6958335 2021-12-19 U-1883 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021588-002 6958335*PED 2022-06-19 Pediatric extension 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021588-001 6958335*PED 2022-06-19 Pediatric extension bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021588-002 6958335*PED 2022-06-19 Pediatric extension bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021588-001 6958335 2021-12-19 U-791 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021588-001 6958335 2021-12-19 U-1883 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021588-001 6958335*PED 2022-06-19 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021588-002 6958335 2021-12-19 U-791 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021588-002 6958335 2021-12-19 U-1883 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021588-002 6958335*PED 2022-06-19 Pediatric extension 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021588-001 6958335 2021-12-19 U-791 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021588-001 6958335 2021-12-19 U-1883 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021588-001 6958335*PED 2022-06-19 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021588-002 6958335 2021-12-19 U-791 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021588-002 6958335 2021-12-19 U-1883 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021588-002 6958335*PED 2022-06-19 Pediatric extension 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021588-001 6958335 2021-12-19 U-791 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021588-001 6958335 2021-12-19 U-1883 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021588-001 6958335*PED 2022-06-19 Pediatric extension 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021588-002 6958335 2021-12-19 U-791 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021588-002 6958335 2021-12-19 U-1883 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021588-002 6958335*PED 2022-06-19 Pediatric extension 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021588-001 6958335 2021-12-19 U-791 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021588-001 6958335 2021-12-19 U-1883 8869cabd3fbd…
Observed Orange Book exclusivity 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 19 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0078-0401 Gleevec imatinib mesylate Novartis Pharmaceuticals Corporation NDA Current 0078-0401 Gleevec imatinib mesylate Novartis Pharmaceuticals Corporation NDA Current 0078-0401 Gleevec imatinib mesylate Novartis Pharmaceuticals Corporation NDA Current 0078-0401 Gleevec imatinib mesylate Novartis Pharmaceuticals Corporation NDA Current 0078-0401 Gleevec imatinib mesylate Novartis Pharmaceuticals Corporation NDA Current 0078-0401 Gleevec imatinib mesylate Novartis Pharmaceuticals Corporation NDA Current 0078-0401 Gleevec imatinib mesylate Novartis Pharmaceuticals Corporation NDA Current 0078-0401 Gleevec imatinib mesylate Novartis Pharmaceuticals Corporation NDA Current 0078-0401 Gleevec imatinib mesylate Novartis Pharmaceuticals Corporation NDA Current 0078-0649 Gleevec imatinib mesylate Novartis Pharmaceuticals Corporation NDA Current 0078-0649 Gleevec imatinib mesylate Novartis Pharmaceuticals Corporation NDA Current 0078-0649 Gleevec imatinib mesylate Novartis Pharmaceuticals Corporation NDA Current 0078-0649 Gleevec imatinib mesylate Novartis Pharmaceuticals Corporation NDA Current 0078-0649 Gleevec imatinib mesylate Novartis Pharmaceuticals Corporation NDA Current 0078-0649 Gleevec imatinib mesylate Novartis Pharmaceuticals Corporation NDA Current 0078-0649 Gleevec imatinib mesylate Novartis Pharmaceuticals Corporation NDA Current 0078-0649 Gleevec imatinib mesylate Novartis Pharmaceuticals Corporation NDA Current 0078-0649 Gleevec imatinib mesylate Novartis Pharmaceuticals Corporation NDA Current 66828-0030 Gleevec imatinib mesylate Novartis Pharma Produktions GmbH NDA Current