FDA.reportPublic FDA data

Application 220071

Type
ANDA
Sponsor
VIWIT PHARM

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 43.

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
A220071-001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2026-03-19
A220071-002LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2026-03-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A220071-001AP
A220071-002AP

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
2026-09-14 22:38:342026-08A220071-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2026-03-1984e616aacf4f…
2026-09-14 22:38:342026-08A220071-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2026-03-1984e616aacf4f…
2026-08-18 06:07:402026-07A220071-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2026-03-19caaa826d4ba7…
2026-08-18 06:07:402026-07A220071-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2026-03-19caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220071-001LIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAP2026-03-19a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220071-002LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP2026-03-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A220071-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A220071-002AP184e616aacf4f…
2026-08-18 06:07:402026-07A220071-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A220071-002AP1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220071-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220071-002AP1a50c72e98297…

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 9 of 16 · 307 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XeroBurn Burn GelLIDOCAINE HYDROCHLORIDEDynarex Corporation58985046-ca9c-12be-e053-2991aa0abe722025-03-13WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDENovagenix Labs LLC7567ffb5-953a-4be9-9a02-c5a50dcd93062025-03-12Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
LidocaineLIDOCAINE HYDROCHLORIDEARMAS PHARMACEUTICALS INC.2f6e0f3d-ceaf-a853-e063-6394a90a8efb2025-03-07Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lightning Products BURN RELIEFLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.555ac696-e761-4a5a-bed8-945dc64d5be52025-02-27WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
LidocaineLIDOCAINE HYDROCHLORIDEFresenius Kabi USA, LLCf1b26274-a55e-4321-b96c-ce0df830f2052025-02-20Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMcKesson Corporation dba SKY Packaginge1eabd6b-9bb8-646f-e053-2a95a90a7b832025-02-20Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDENorthStar RxLLC6a7fa6c5-b550-46ac-99a3-5c49339e6dbd2025-02-19Warnings, Adverse reactionsName fallback
brand name: Lidocaine hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEEugia US LLC9916b09d-a116-469d-92d5-60e50ea9782b2025-02-07Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
TheraCare Pain Relieving Lidocaine CreamLIDOCAINE HYDROCHLORIDEVeridian Healthcare2d42192b-8889-a896-e063-6294a90a4fc82025-02-03WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEEugia US LLCccc38d8a-43fd-44c0-985e-32af9ed956ab2025-02-03Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharmad5e23ede-957c-4a32-b1c6-268acb773c312025-01-31Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
INTIMALE LIDOCAINE DELAYLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED5ddd7d56-bf51-462b-afcd-944861e497812025-01-28WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Meijer Odor Free Analgesic Pain Relieving Topical AnalgesicLIDOCAINE HYDROCHLORIDEMeijer Distribution, Inc6288efea-f636-4eea-bb9f-78aa2f9af54a2025-01-14WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
IKONIK TONIKLIDOCAINE HYDROCHLORIDEIKONIK CARE, LLC122fdfe8-b5fa-46d1-9fd9-3df9887ed3202025-01-14WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Burn JelLIDOCAINE HYDROCHLORIDEWater-Jel Technologiesff621b46-2342-41db-994d-851a09796d082025-01-06WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf4c19cf5-c8b1-5e9f-e053-2995a90aee532024-12-31Warnings, Adverse reactionsName fallback
brand name: Lidocaine hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
HealthWise 4% Lidocaine CreamLIDOCAINE HYDROCHLORIDEVeridian Healthcare0fb2af30-7f2d-c7c4-e063-6294a90a37f72024-12-19WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine ViscousLIDOCAINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.79b42076-359d-4258-b1d8-f40e67ac54242024-12-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Serum XLIDOCAINE HYDROCHLORIDEAO Biologix, LLCe07b6268-6400-6849-e053-2a95a90a8b3e2024-12-11WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMcKesson Corporation dba SKY Packaging903cd7bd-6c3d-4068-bb24-e91b1ca1393d2024-12-10Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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