FDA.reportPublic FDA data

Application 020539

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LAMISILTERBINAFINE HYDROCHLORIDETABLET;ORALEQ 250MG BASEYesYes

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
N020539-001LAMISILTERBINAFINE HYDROCHLORIDEEQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-05-10

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 UTC2022-10N020539-001LAMISILEQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-05-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020539-001LAMISILEQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-05-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020539-001LAMISILEQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-05-10cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020539-001LAMISILEQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-05-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N020539-001AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020539-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020539-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020539-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020539-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020539-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N020539-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020539-001AB1ea99ee380514…

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 3 · 59 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
terbinafine hydrochlorideTERBINAFINE HYDROCHLORIDEREMEDYREPACK INC.2886b2ff-815f-4621-bc28-1fea082c19202026-07-09Warnings, Adverse reactionsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Athlete Foot CreamTERBINAFINE HYDROCHLORIDEBeautivity LLC3b2c1d7f-32c3-aa3b-e063-6394a90a62672026-06-29WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEScholl's Wellness Company LLC31f59302-eaee-211b-e063-6294a90a08b02026-04-03WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
TerbinafineTERBINAFINE HYDROCHLORIDEAmerican Health Packaging4ee1b667-0cf6-46e4-a740-4fc27904d5772026-03-06Warnings, Adverse reactionsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.92b31fc4-0f02-4857-b11f-49b9f942ee842026-02-20WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
TerbinafineTERBINAFINE HYDROCHLORIDEREMEDYREPACK INC.44c6f6e7-e0c0-450e-83ce-1ed4f3efddec2026-02-13Warnings, Adverse reactionsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDENorthwind Health Company, LLCab6f50a5-87ce-0819-e053-2a95a90a22b72026-01-01Warnings, Adverse reactionsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
TerbinafineTERBINAFINE HYDROCHLORIDEA-S Medication Solutions5de4c245-7086-453b-b90a-7a1242ec2c0b2025-12-18Warnings, Adverse reactionsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Lamisil ATTERBINAFINE HYDROCHLORIDEKaro Healthcare Inc.21f1bf77-4338-4b75-b513-80a0d98a722a2025-12-12WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Lamisil ATTERBINAFINE HYDROCHLORIDEKaro Healthcare Inc.d3e75665-e2d4-47d9-baaa-93817b5fbf002025-12-12WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Walgreens Athletes FootTERBINAFINE HYDROCHLORIDEWalgreen Companyd706c56f-0123-4a5a-8c85-240cbe6ef7a52025-11-26WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
CVSTERBINAFINE HYDROCHLORIDECVS Pharmacy17684ba2-3c2c-4259-84fa-3833f19e5a4d2025-11-25WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEGolden State Medical Supply, Inc.b43e4644-024c-4aa6-b403-19152c7858022025-11-25Warnings, Adverse reactionsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Lamisil AT CreamTERBINAFINE HYDROCHLORIDEVoyant Beauty Inc.9dea4789-bf1c-1577-e053-2a95a90a53812025-11-18WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Good Neighbor PharmacyTERBINAFINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.0a9e890c-1eed-4fde-a484-852a4dd135c22025-10-17WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.2df111dc-ecac-4161-9e22-38436eb37c1f2025-10-17Warnings, Adverse reactionsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
TerbinafineTERBINAFINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.747fdc13-7c3a-4672-b50c-31c51037bda22025-10-14Warnings, Adverse reactionsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Lamisil AT CreamTERBINAFINE HYDROCHLORIDEKaro Healthcare Inc.1aa5e03a-432b-4154-ab6e-6dbce7a671092025-10-02WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
CVS Pharmacy Athletes FootTERBINAFINE HYDROCHLORIDECVS Pharmacy98a4ed66-2813-49de-8cda-94c41cc3ca9f2025-09-25WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE
Athletes FootTERBINAFINE HYDROCHLORIDEPublix Super Markets Inc.58293d62-089d-49ab-b691-dfd705ac9a9c2025-09-25WarningsName fallback
generic name: TERBINAFINE HYDROCHLORIDE

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0179Lamisilterbinafine hydrochlorideNovartis Pharmaceuticals NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58212SUPPL2019-04-04
58174SUPPL2019-04-02
58168SUPPL2019-04-01
46956SUPPL2017-01-24
46949SUPPL2017-01-24
45402SUPPL2016-09-28
45232SUPPL2016-08-23
25138SUPPL2013-10-25
12697SUPPL2013-10-25
2692SUPPL2013-06-18
34801SUPPL2013-06-17
34800SUPPL2012-05-02
2691SUPPL2012-04-27
34799SUPPL2012-03-22
25137SUPPL2011-11-08
34798SUPPL2011-04-01
2690SUPPL2011-03-31
2689SUPPL2010-12-06
34797SUPPL2010-12-04
34796SUPPL2004-02-03
2688SUPPL2004-02-02
25135ORIG2001-05-03
25136SUPPL2001-04-13