Application 021014

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRILEPTALOXCARBAZEPINETABLET;ORAL150MGYesNo
002TRILEPTALOXCARBAZEPINETABLET;ORAL300MGYesNo
003TRILEPTALOXCARBAZEPINETABLET;ORAL600MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021014-001TRILEPTALOXCARBAZEPINE150MGTABLET / ORALABRLD2000-01-14
N021014-002TRILEPTALOXCARBAZEPINE300MGTABLET / ORALABRLD2000-01-14
N021014-003TRILEPTALOXCARBAZEPINE600MGTABLET / ORALABRLD, RS2000-01-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N021014-001AB
N021014-002AB
N021014-003AB

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N021014-001TRILEPTAL150MGTABLET / ORALABRLD2000-01-14c2088c7a36db…
2026-10-15 13:18:302026-09N021014-002TRILEPTAL300MGTABLET / ORALABRLD2000-01-14c2088c7a36db…
2026-10-15 13:18:302026-09N021014-003TRILEPTAL600MGTABLET / ORALABRLD, RS2000-01-14c2088c7a36db…
2026-09-14 22:38:342026-08N021014-001TRILEPTAL150MGTABLET / ORALABRLD2000-01-1484e616aacf4f…
2026-09-14 22:38:342026-08N021014-002TRILEPTAL300MGTABLET / ORALABRLD2000-01-1484e616aacf4f…
2026-09-14 22:38:342026-08N021014-003TRILEPTAL600MGTABLET / ORALABRLD, RS2000-01-1484e616aacf4f…
2026-08-18 06:07:402026-07N021014-001TRILEPTAL150MGTABLET / ORALABRLD2000-01-14caaa826d4ba7…
2026-08-18 06:07:402026-07N021014-002TRILEPTAL300MGTABLET / ORALABRLD2000-01-14caaa826d4ba7…
2026-08-18 06:07:402026-07N021014-003TRILEPTAL600MGTABLET / ORALABRLD, RS2000-01-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021014-001TRILEPTAL150MGTABLET / ORALABRLD2000-01-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021014-002TRILEPTAL300MGTABLET / ORALABRLD2000-01-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021014-003TRILEPTAL600MGTABLET / ORALABRLD, RS2000-01-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021014-001TRILEPTAL150MGTABLET / ORALABRLD2000-01-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021014-002TRILEPTAL300MGTABLET / ORALABRLD2000-01-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021014-003TRILEPTAL600MGTABLET / ORALABRLD, RS2000-01-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N021014-001TRILEPTAL150MGTABLET / ORALABRLD2000-01-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021014-002TRILEPTAL300MGTABLET / ORALABRLD2000-01-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021014-003TRILEPTAL600MGTABLET / ORALABRLD, RS2000-01-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021014-001TRILEPTAL150MGTABLET / ORALABRLD2000-01-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021014-002TRILEPTAL300MGTABLET / ORALABRLD2000-01-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021014-003TRILEPTAL600MGTABLET / ORALABRLD, RS2000-01-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021014-001TRILEPTAL150MGTABLET / ORALABRLD2000-01-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021014-002TRILEPTAL300MGTABLET / ORALABRLD2000-01-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021014-003TRILEPTAL600MGTABLET / ORALABRLD, RS2000-01-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021014-001TRILEPTAL150MGTABLET / ORALABRLD2000-01-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021014-002TRILEPTAL300MGTABLET / ORALABRLD2000-01-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021014-003TRILEPTAL600MGTABLET / ORALABRLD, RS2000-01-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021014-001TRILEPTAL150MGTABLET / ORALABRLD2000-01-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021014-002TRILEPTAL300MGTABLET / ORALABRLD2000-01-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021014-003TRILEPTAL600MGTABLET / ORALABRLD, RS2000-01-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021014-001TRILEPTAL150MGTABLET / ORALABRLD2000-01-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021014-002TRILEPTAL300MGTABLET / ORALABRLD2000-01-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021014-003TRILEPTAL600MGTABLET / ORALABRLD, RS2000-01-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021014-001TRILEPTAL150MGTABLET / ORALABRLD2000-01-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021014-002TRILEPTAL300MGTABLET / ORALABRLD2000-01-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021014-003TRILEPTAL600MGTABLET / ORALABRLD, RS2000-01-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021014-001TRILEPTAL150MGTABLET / ORALABRLD2000-01-14d06236e962d9…
2024-10-29 15:01 UTC2024-10N021014-002TRILEPTAL300MGTABLET / ORALABRLD2000-01-14d06236e962d9…
2024-10-29 15:01 UTC2024-10N021014-003TRILEPTAL600MGTABLET / ORALABRLD, RS2000-01-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021014-001TRILEPTAL150MGTABLET / ORALABRLD2000-01-1479d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N021014-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09N021014-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09N021014-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08N021014-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N021014-002AB184e616aacf4f…
2026-09-14 22:38:342026-08N021014-003AB184e616aacf4f…
2026-08-18 06:07:402026-07N021014-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021014-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021014-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021014-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021014-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021014-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021014-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021014-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021014-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021014-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021014-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021014-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021014-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021014-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021014-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021014-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021014-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021014-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021014-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021014-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021014-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021014-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021014-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021014-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021014-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021014-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021014-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021014-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021014-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021014-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021014-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021014-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021014-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021014-001AB179d66fd596c7…

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 3 of 4 · 68 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OxcarbazepineOXCARBAZEPINEAjanta Pharma USA Inc.d947e9b1-2a15-4048-bb4e-fe56b68518482025-11-30Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEBionpharma Inc.ec033897-21b4-4d08-83de-042783e892512025-11-28Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.a1b6a698-f7d9-4adb-9e38-b63e7a85e2b32025-10-24Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.1176d5f5-3447-4925-aed8-1a1cb4b5989d2025-10-13Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEAmneal Pharmaceuticals LLC2515391e-3a88-4226-92e5-f641c8409fe52025-10-01Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINECoupler LLC3f15c889-4386-850b-e063-6294a90a8dbf2025-09-18Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEPreferred Pharmaceuticals Inc.e156339c-f79e-4a20-b9da-f50bea9482132025-09-05Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
oxcarbazepineOXCARBAZEPINEMacleods Pharmaceuticals Limited962098cc-2d84-4723-a296-b110f1fd659e2025-08-29Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEMarlex Pharmaceuticals, Incd3684d55-0564-4849-bdf6-b91f22a3e28c2025-06-25Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEIngenus Pharmaceuticals, LLC70798ca9-0eda-49c0-8a7c-b775b6ae3d692025-04-12Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEProficient Rx LP433d9d03-a36e-42c6-8e4d-f333ed60e45a2025-03-01Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINENorthStar RxLLC1746d95f-c529-45ba-a520-0c135e8edda82025-02-03Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEDirectRxdbea45c2-e166-b557-e053-2995a90a76432025-01-22Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEBryant Ranch Prepack23137a89-cbd0-4a5f-8220-f26b7ba543302025-01-21Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEAvPAKfd8da0e9-d69b-7587-e053-6294a90a33c02025-01-09Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEEPIC PHARMA, LLC62ab716b-f05f-454d-95b3-1a382cdf72262025-01-07Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINENovadoz Pharmaceuticals LLC03bec567-a9c3-4d82-9679-fec5324d0df62024-11-18Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEBryant Ranch Prepack38694974-3dc6-42b5-bdf9-b5354e35330b2024-10-25Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OxcarbazepineOXCARBAZEPINEDirect_rx21b0cc84-b64a-75de-e063-6294a90a9dd02024-09-09Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE
OXCARBAZEPINEOXCARBAZEPINEBryant Ranch Prepackd8edaa2b-3bab-4030-a4e3-0c77f76557312024-07-16Warnings, Adverse reactionsName fallback
generic name: OXCARBAZEPINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0337TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0337TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0337TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0337TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0337TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0337TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0337TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0456TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0456TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0456TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0456TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0456TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0456TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0456TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0457TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0457TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0457TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0457TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0457TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0457TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
0078-0457TrileptaloxcarbazepineNovartis Pharmaceuticals CorporationNDACurrent
55289-007TrileptaloxcarbazepinePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-007TrileptaloxcarbazepinePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-007TrileptaloxcarbazepinePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-007TrileptaloxcarbazepinePD-Rx Pharmaceuticals, Inc.NDACurrent
70518-1300TrileptaloxcarbazepineREMEDYREPACK INC.NDACurrent
70518-1300TrileptaloxcarbazepineREMEDYREPACK INC.NDACurrent
70518-1349TrileptaloxcarbazepineREMEDYREPACK INC.NDACurrent
70518-1349TrileptaloxcarbazepineREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83527SUPPL 2025-09-26
83526SUPPL 2025-09-26
83435SUPPL 2025-09-25
81207SUPPL 2025-02-11
81206SUPPL 2025-02-11
79543SUPPL 2024-09-05
79541SUPPL 2024-09-05
57415SUPPL2019-02-04
57136SUPPL2019-01-08
53501SUPPL2018-03-28
53242SUPPL2018-03-23
53236SUPPL2018-03-23
50489SUPPL2017-11-27
50460SUPPL2017-11-20
47726SUPPL2017-03-28
47668SUPPL2017-03-24
35890SUPPL2014-07-08
4044SUPPL2014-07-08
14165SUPPL2014-06-10
4045SUPPL2014-06-10
35889SUPPL2013-02-12
4043SUPPL2013-02-12
26490SUPPL2011-11-14
35888SUPPL2011-03-21
35887SUPPL2011-03-21
35885SUPPL2011-03-21
35884SUPPL2011-03-21
35883SUPPL2011-03-21
14164SUPPL2011-03-21
14163SUPPL2011-03-21
26489SUPPL2011-03-08
26487SUPPL2011-03-08
26486SUPPL2011-03-08
4042SUPPL2011-03-08
4041SUPPL2011-03-08
4040SUPPL2011-03-08
4038SUPPL2011-03-08
35886SUPPL2009-05-12
26488SUPPL2009-05-04
4039SUPPL2007-09-06
24144ORIG2007-03-16
41877SUPPL2006-05-31
26485SUPPL2005-11-18
26484SUPPL2005-11-01
14162SUPPL2005-10-28
14161SUPPL2005-03-30
4037SUPPL2005-03-30
35882SUPPL2003-08-15
4034SUPPL2003-08-15
4036SUPPL2003-04-15
4035SUPPL2002-04-01
41876ORIG2002-02-28
35881ORIG1999-01-10
26483ORIG1999-01-10
52101SUPPL1900-01-01
52099SUPPL1900-01-01
52096SUPPL1900-01-01
52094SUPPL1900-01-01