FDA.reportPublic FDA data

Application 203265

Type
ANDA
Sponsor
NOVEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIDOCAINELIDOCAINEPATCH;TOPICAL5%NoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203265-001LIDOCAINELIDOCAINE5%PATCH / TOPICAL2020-12-01

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A203265-001LIDOCAINE5%PATCH / TOPICAL2020-12-01a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 26 · 506 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspercreme with Lidocaine DryLIDOCAINEChattem, Inc.008abaaa-5e12-4246-a7f5-66f3966acf282026-07-30WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEBenco Dentalc5cc87df-df3f-42b8-af84-5f2045d420842026-07-30Warnings, Adverse reactionsName fallback
brand name: Lidocaine
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEBenco Dental9419ac39-9b26-4cca-a2d6-167205fede242026-07-28Warnings, Adverse reactionsName fallback
brand name: Lidocaine
LIDOCAINELIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEPatterson Dental6506755f-c9f7-4286-9ba7-ac5d5745f5e42026-07-28Warnings, Adverse reactionsName fallback
brand name: LIDOCAINE
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEDarby Dental Supply, LLC27e8fdfb-e923-4f99-aff7-8b9e502281512026-07-27Warnings, Adverse reactionsName fallback
brand name: Lidocaine
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEDarby Dental Supply, LLCe5ed4c2a-e320-48cf-a2fd-61d48481c6242026-07-27Warnings, Adverse reactionsName fallback
brand name: Lidocaine
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEPatterson Dentalf074c0dc-7c3f-46fd-a480-b8337a19fe5c2026-07-27Warnings, Adverse reactionsName fallback
brand name: Lidocaine
Lidfix Pain Relief Patch LidocaineLIDOCAINEHETERO HEALTHCARE LIMITED2149f0e3-1983-4f02-929e-ecd20357f4bb2026-07-27WarningsName fallback
generic name: LIDOCAINE
RectoProtectLIDOCAINEAkron Pharma Inc.1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb2026-07-27WarningsName fallback
generic name: LIDOCAINE
NUMBINGLIDOCAINEYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED578675e8-30e7-6986-e063-6394a90a8afe2026-07-26WarningsName fallback
generic name: LIDOCAINE
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd578fa642-ff30-e511-e063-6294a90a59872026-07-26WarningsName fallback
generic name: LIDOCAINE
Pain Relief Patch LidocaineLIDOCAINEHyVee41c26a66-3371-2c2c-e063-6294a90aa38b2026-07-22WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINEShaanxi Shuvita Biotech Co., Ltd572b95a1-11b2-6328-e063-6394a90acb732026-07-21WarningsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
RectaEase Hemorrhoid Relief CreamLIDOCAINETrifecta Pharmaceuticals USA LLCc054921a-9f1b-7c75-e053-2995a90a17382026-07-20WarningsName fallback
generic name: LIDOCAINE
VBBV NumbingLIDOCAINEJiashen International Trade Limited5716c36b-6e97-c294-e063-6394a90aaf5c2026-07-20WarningsName fallback
generic name: LIDOCAINE
Burn ReliefLIDOCAINEPremier Brands of America Inc.560c29cc-2453-5d14-e063-6394a90a844f2026-07-17WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINEA-S Medication Solutions2bb5b298-3802-446c-b8cd-313e84bff04e2026-07-15Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
LidocaineLIDOCAINEASCLEMED USA INC.56a54ef4-7aa0-e181-e063-6394a90a3e0e2026-07-15Warnings, Adverse reactionsName fallback
brand name: Lidocaine
generic name: LIDOCAINE
Lidocaine Numbing CreamLIDOCAINEKORVIA GLOBAL Inc.5690db03-4d62-9660-e063-6394a90a2fc02026-07-14WarningsName fallback
generic name: LIDOCAINE
Lidocaine Pain Relief Gel -PatchLIDOCAINEGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.51d32d7c-3ba7-81cd-e063-6294a90a20412026-07-14WarningsName fallback
generic name: LIDOCAINE

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
66993-342Lidocaine Patch, 5%LidocainePrasco LaboratoriesANDACurrent