Home Applications 021285 Application 021285
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TRILEPTAL OXCARBAZEPINE SUSPENSION;ORAL 300MG/5ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021285-001 TRILEPTAL OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021285-001 AB
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 2 · 41 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 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021285-001 8119148 2020-12-19 U-724 Drug product 2012-03-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021285-001 8119148*PED 2021-06-19 Pediatric extension 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N021285-001 8119148*PED 2021-06-19 Pediatric extension 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021285-001 8119148*PED 2021-06-19 Pediatric extension 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021285-001 8119148*PED 2021-06-19 Pediatric extension 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021285-001 8119148 2020-12-19 U-724 Drug product 2012-03-08 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021285-001 8119148*PED 2021-06-19 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021285-001 8119148 2020-12-19 U-724 Drug product 2012-03-08 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021285-001 8119148*PED 2021-06-19 Pediatric extension c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021285-001 8119148 2020-12-19 U-724 Drug product 2012-03-08 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021285-001 8119148*PED 2021-06-19 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021285-001 8119148 2020-12-19 U-724 Drug product 2012-03-08 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021285-001 8119148*PED 2021-06-19 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021285-001 8119148 2020-12-19 U-724 Drug product 2012-03-08 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021285-001 8119148*PED 2021-06-19 Pediatric extension ea99ee380514…
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 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0078-0357 Trileptal oxcarbazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0357 Trileptal oxcarbazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0357 Trileptal oxcarbazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0357 Trileptal oxcarbazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0357 Trileptal oxcarbazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0357 Trileptal oxcarbazepine Novartis Pharmaceuticals Corporation NDA Current 0078-0357 Trileptal oxcarbazepine Novartis Pharmaceuticals Corporation NDA Current 0781-6270 Oxcarbazepine oxcarbazepine Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-6270 Oxcarbazepine oxcarbazepine Sandoz Inc NDA AUTHORIZED GENERIC Current 0781-6270 Oxcarbazepine oxcarbazepine Sandoz Inc NDA AUTHORIZED GENERIC Current