Home Applications 021014 Application 021014
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TRILEPTAL OXCARBAZEPINE TABLET;ORAL 150MG Yes No 002 TRILEPTAL OXCARBAZEPINE TABLET;ORAL 300MG Yes No 003 TRILEPTAL OXCARBAZEPINE TABLET;ORAL 600MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021014-001 TRILEPTAL OXCARBAZEPINE 150MG TABLET / ORAL AB RLD 2000-01-14 N021014-002 TRILEPTAL OXCARBAZEPINE 300MG TABLET / ORAL AB RLD 2000-01-14 N021014-003 TRILEPTAL OXCARBAZEPINE 600MG TABLET / ORAL AB RLD, RS 2000-01-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 · 123 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 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 29 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0078-0337 Trileptal oxcarbazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0337 Trileptal oxcarbazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0337 Trileptal oxcarbazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0337 Trileptal oxcarbazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0337 Trileptal oxcarbazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0337 Trileptal oxcarbazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0337 Trileptal oxcarbazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0456 Trileptal oxcarbazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0456 Trileptal oxcarbazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0456 Trileptal oxcarbazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0456 Trileptal oxcarbazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0456 Trileptal oxcarbazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0456 Trileptal oxcarbazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0456 Trileptal oxcarbazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0457 Trileptal oxcarbazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0457 Trileptal oxcarbazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0457 Trileptal oxcarbazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0457 Trileptal oxcarbazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0457 Trileptal oxcarbazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0457 Trileptal oxcarbazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0457 Trileptal oxcarbazepine Novartis Pharmaceuticals Corporation NDA Current 55289-007 Trileptal oxcarbazepine PD-Rx Pharmaceuticals, Inc. NDA Current 55289-007 Trileptal oxcarbazepine PD-Rx Pharmaceuticals, Inc. NDA Current 55289-007 Trileptal oxcarbazepine PD-Rx Pharmaceuticals, Inc. NDA Current 55289-007 Trileptal oxcarbazepine PD-Rx Pharmaceuticals, Inc. NDA Current 70518-1300 Trileptal oxcarbazepine REMEDYREPACK INC. NDA Current 70518-1300 Trileptal oxcarbazepine REMEDYREPACK INC. NDA Current 70518-1349 Trileptal oxcarbazepine REMEDYREPACK INC. NDA Current 70518-1349 Trileptal oxcarbazepine REMEDYREPACK INC. NDA Current