FDA.reportPublic FDA data

Application 018281

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TEGRETOLCARBAMAZEPINETABLET, CHEWABLE;ORAL100MGYesYes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018281-001TEGRETOLCARBAMAZEPINE100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, Approved before 1982

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N018281-001TEGRETOL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018281-001TEGRETOL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018281-001TEGRETOL100MGTABLET, CHEWABLE / ORALRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018281-001TEGRETOL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N018281-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12N018281-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N018281-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018281-001AB1ea99ee380514…

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 4 · 74 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarbamazepineCARBAMAZEPINEApotex Corp.e91f9de3-3fdd-0a6b-71ce-53a2cc1428162026-09-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBAMAZEPINE
CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.5f9535b1-ff6a-41b3-bbb2-efcf8fbacf4c2026-08-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBAMAZEPINE
carbamazepineCARBAMAZEPINENorthstar Rx LLCc91a5a1b-5481-445b-86e8-f10109ac39372026-08-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBAMAZEPINE
CARBAMAZEPINECARBAMAZEPINEApotex Corp.bf0d012f-da14-8ce3-d74f-56172cddebc52026-08-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBAMAZEPINE
CarbamazepineCARBAMAZEPINEAscend Laboratories, LLCf0a254c5-bd33-4b14-b9f0-830b3438f5c62026-08-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBAMAZEPINE
TegretolCARBAMAZEPINENovartis Pharmaceuticals Corporation8d409411-aa9f-4f3a-a52c-fbcb0c3ec0532026-08-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tegretol
generic name: CARBAMAZEPINE
CarbatrolCARBAMAZEPINETakeda Pharmaceuticals America, Inc.bc03e499-5bac-4293-bff4-6864153a624d2026-08-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBAMAZEPINE
CarbamazepineCARBAMAZEPINEUnichem Pharmaceuticals (USA), Inc.50ba2042-fc67-4266-a773-a30f07649a5a2026-08-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBAMAZEPINE
CarbamazepineCARBAMAZEPINEUmedica Laboratories USA Inc.48080efd-1781-4585-83f8-c43957ac63b32026-08-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBAMAZEPINE
CarbamazepineCARBAMAZEPINEUmedica Laboratories USA Inc.f3465f71-8931-43b6-baea-eac7046a44002026-08-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBAMAZEPINE
CARBAMAZEPINECARBAMAZEPINEAlembic Pharmaceuticals Inc.87d343a8-84d5-4cdd-b0a0-629311b51f112026-08-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBAMAZEPINE
carbamazepineCARBAMAZEPINEZydus Lifesciences Limitedd10e5f83-56db-4bc9-8c51-150a2e3e20ea2026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBAMAZEPINE
carbamazepineCARBAMAZEPINEZydus Pharmaceuticals (USA) Inc.c5e4a25a-0137-4327-96f5-15735891ad5c2026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBAMAZEPINE
CarbamazepineCARBAMAZEPINETorrent Pharmaceuticals Limited7c4860c1-daba-4e0f-97fd-d30cbc8603a22026-08-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBAMAZEPINE
CARBAMAZEPINECARBAMAZEPINETorrent Pharmaceuticals Limited97e6e175-75e8-437b-b457-ddb1ae4e857d2026-07-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBAMAZEPINE
CARBAMAZEPINECARBAMAZEPINEAmerican Health Packaging7108d630-89bc-4815-b6fb-a1f4676c496e2026-07-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBAMAZEPINE
CARBAMAZEPINECARBAMAZEPINEBionpharma Inc.,138d9ed1-2f8e-d19d-e063-6394a90a695d2026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBAMAZEPINE
CARBAMAZEPINECARBAMAZEPINECoupler LLC5461e739-0f18-b012-e063-6394a90a6b142026-06-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBAMAZEPINE
CarbamazepineCARBAMAZEPINECoupler LLC544e3b55-c8a3-a480-e063-6394a90abbb52026-06-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBAMAZEPINE
CarbamazepineCARBAMAZEPINEREMEDYREPACK INC.cd8b51f4-8427-4b18-9d2c-10771d2a65802026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBAMAZEPINE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53451SUPPL2018-03-27
53419SUPPL2018-03-26
53149SUPPL2018-03-22
33468SUPPL2015-09-03
889SUPPL2015-09-01
33469SUPPL2014-09-19
14967SUPPL2014-09-17
14970SUPPL2014-01-17
11196SUPPL2014-01-17
14971SUPPL2013-03-08
11197SUPPL2013-03-08
14972SUPPL2012-12-13
11198SUPPL2012-12-13
33470SUPPL2011-03-07
14969SUPPL2011-03-07
11195SUPPL2011-03-07
890SUPPL2011-03-07
11194SUPPL2009-05-12
14968SUPPL2009-05-01
14966SUPPL2008-01-09
11193SUPPL2007-12-12
14965SUPPL2007-08-17
11192SUPPL2007-08-17
40794SUPPL2007-07-06
20122SUPPL2007-07-06
33467SUPPL2001-03-07
888SUPPL2001-03-07