FDA.reportPublic FDA data

Application 214267

Type
ANDA
Sponsor
SINTETICA SA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION1%NoNo
002LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION2%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214267-001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2022-09-19
A214267-002LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2022-09-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A214267-001AP
A214267-002AP

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 22:54:322026-06A214267-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2022-09-19a50c72e98297…
2026-08-01 22:54:322026-06A214267-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2022-09-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A214267-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A214267-002AP1a50c72e98297…

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 16 · 306 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Xylocaine MPFLIDOCAINE HYDROCHLORIDESportpharm LLC50aa6133-0776-4714-9821-fe8581f635ca2026-07-28Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Aspercreme Lidocaine with Rosemary and MintLIDOCAINE HYDROCHLORIDEChattem, Inc.9d40bfea-85d0-4943-83e9-0c16e79a011c2026-07-28WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCf8fa72db-5f7a-4158-a2b3-f8bc0e12df9f2026-07-24WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCa32cbc19-ec30-4634-b70d-664f2a2edd952026-07-24WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC573a7298-b02e-230c-e063-6294a90a269c2026-07-22Warnings, Adverse reactionsName fallback
brand name: Lidocaine hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.462e9498-9eb9-456a-9022-659bcff93e3f2026-07-17Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
Painsil Pain Relief Roll-OnLIDOCAINE HYDROCHLORIDEPainsil LLCdee39dff-5749-4ef2-a9ed-182f25e01f672026-07-14WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHenry Schein, Inc.fa7dedcd-d78b-45f2-9dd7-f273043167d02026-07-14Warnings, Adverse reactionsName fallback
brand name: LIDOCAINE HYDROCHLORIDE
generic name: LIDOCAINE HYDROCHLORIDE
ZyloReliefLIDOCAINE HYDROCHLORIDEHighmark Pharma LLC635f5b98-f74c-495f-a537-686fcba9ccad2026-07-14WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst2177b6fe-aa37-6f6b-e063-6294a90af09a2026-07-10Warnings, Adverse reactionsName fallback
brand name: LIDOCAINE HYDROCHLORIDE
generic name: LIDOCAINE HYDROCHLORIDE
TopCare Health Pain ReliefLIDOCAINE HYDROCHLORIDETopco Associates LLC485b0671-da09-19d7-e063-6294a90aca5d2026-07-03WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
JJ Care BURNLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.d69ebc53-8552-449a-a973-f211328a3d3e2026-07-03WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Desert Harvest Releveum with LidocaineLIDOCAINE HYDROCHLORIDEDesert Harvest, Inc9ad514ab-a6bd-4564-8ba3-0149032ebf362026-07-01WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHenry Schein, Inc.cfbca641-aeee-4dc8-a340-30c53d3b023b2026-07-01Warnings, Adverse reactionsName fallback
brand name: LIDOCAINE HYDROCHLORIDE
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.9c18eaf1-4a0b-4916-70b2-88a8274947112026-06-24Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
Lidozall ProLIDOCAINE HYDROCHLORIDEV2 Pharma LLCecc26ba7-4ff6-43e6-bfb9-91a9cbb509ff2026-06-16WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDECivica, Inc.3c3b3888-fad3-440b-b627-6f79a2f4668f2026-06-10Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
HealthWise Pain Relief Cream with LidocaineLIDOCAINE HYDROCHLORIDEVeridian Healthcareef176d33-10b9-ddb2-e053-2995a90a76e32026-06-10WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ad1ef0a8-88db-4648-c098-d009eaeb4e5b2026-06-09Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
Aspercreme with lidocaine No-Mess Applicator Two PackLIDOCAINE HYDROCHLORIDEChattem, Inc.8092cde7-28d0-4755-b5c0-5765934e572f2026-05-29WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68055-641NALIDOCAINE HYDROCHLORIDESINTETICA SAANDACurrent
68055-642NALIDOCAINE HYDROCHLORIDESINTETICA SAANDACurrent
68055-643NALIDOCAINE HYDROCHLORIDESINTETICA SAANDACurrent
68055-645NALIDOCAINE HYDROCHLORIDESINTETICA SAANDACurrent
68055-646NALIDOCAINE HYDROCHLORIDESINTETICA SAANDACurrent
68055-647NALIDOCAINE HYDROCHLORIDESINTETICA SAANDACurrent
83090-001NALIDOCAINE HYDROCHLORIDESintetica US LLCANDACurrent
83090-002NALIDOCAINE HYDROCHLORIDESintetica US LLCANDACurrent
83090-003NALIDOCAINE HYDROCHLORIDESintetica US LLCANDACurrent
83090-004NALIDOCAINE HYDROCHLORIDESintetica US LLCANDACurrent
83090-005NALIDOCAINE HYDROCHLORIDESintetica US LLCANDACurrent
83090-006NALIDOCAINE HYDROCHLORIDESintetica US LLCANDACurrent