FDA.reportPublic FDA data

Application 080409

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LTA II KITLIDOCAINE HYDROCHLORIDESOLUTION;TOPICAL4%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
A080409-001LTA II KITLIDOCAINE HYDROCHLORIDE4%SOLUTION / TOPICALApproved 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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A080409-001LTA II KIT4%SOLUTION / TOPICALApproved before 1982a50c72e98297…

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 2 of 15 · 300 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESportpharm LLC5b74b6f4-f26f-4243-8060-cd17779079842026-05-25Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.89a4bd73-89f4-4fd7-2c9f-921e1da8f96b2026-05-22Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.55aa77b8-7601-4432-8631-bfec58daf2472026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
First Aid Only Lidocaine Hydrochloride Analgesic Burn GelLIDOCAINE HYDROCHLORIDEAcme United Corporation5258cef2-0e5c-4ccd-e063-6394a90a9e5c2026-05-21WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDECardinal Health 107, LLCafd7c91b-3283-49e7-b79f-1c8d0c1a53bd2026-05-20Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lightning X Burn Relief GelLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.515eb4cc-63af-c11d-e063-6294a90a13ca2026-05-09WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
EVERLIT CARE PRODUCTS BURN RELIEFLIDOCAINE HYDROCHLORIDEEVERLIT GLOBAL INC.d7ec5720-4d1f-4943-ae36-c7d6acbae7d72026-05-04WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
EVERLIT CARE PRODUCTS BURN RELIEFLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.5371dae4-ea63-46cc-ac26-5418f359c63e2026-05-04WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
FIRSTAR BURNLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.186343c5-2e71-49c4-8d64-5fb3131239fa2026-05-04WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma9920daef-b156-4a14-b641-f714191ffb5c2026-04-28Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
LidocaineLIDOCAINE HYDROCHLORIDESportpharm LLCcffda6fc-7e85-4c48-9623-2551d3552d7d2026-04-24Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDECamber Pharmaceuticals, Inc.7f202319-effa-4dd8-b871-e720b75f4a832026-04-23Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEBryant Ranch Prepack850bdb6a-85d9-441d-8666-7a61311386b62026-04-23Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
LidocaineLIDOCAINE HYDROCHLORIDESportpharm LLC7adb9ab0-ef91-4c51-baa3-a0b7e12df0772026-04-21Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEBryant Ranch Prepack8f79b023-9bd1-4bd6-8fd0-f9efe88abec02026-04-20Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDECamber Pharmaceuticals, Inc.9a1418e2-b208-4e5c-b5f8-21b3a691a5782026-04-13Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
TATTOO NUMBX NUMBING PAIN RELIEVINGLIDOCAINE HYDROCHLORIDEScyberco Ltdac8eac04-ed5b-4c8e-9f9b-54d160b746062026-04-02WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDEREMEDYREPACK INC.adc4dd69-45f3-48fe-bf85-f014b384c38e2026-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.1631e5ca-03d0-4d3b-91e3-2dc14f4eb0e12026-04-01Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Burn MistLIDOCAINE HYDROCHLORIDEWater-Jel Technologiesc53ab9dd-351a-400b-b873-4f396e0af54d2026-03-31WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE