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 16 of 16 · 307 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SunBurnt PLUS Pain ReliefLIDOCAINE HYDROCHLORIDEWelmedix LLC dba Welmedix Consumer Healthcare6363c695-f801-407d-a4e1-b0d9cfa0a2732018-03-13WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
FSK-5LIDOCAINE HYDROCHLORIDEWater-Jel Technologies4c62196a-9f94-4823-b95f-447f012f10bf2017-12-07WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
EBSS-5LIDOCAINE HYDROCHLORIDEWater-Jel Technologies7e21b96a-3d89-4d1c-9ec6-0611f6c9c6252017-12-07WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
IWK-5LIDOCAINE HYDROCHLORIDEWater-Jel Technologiesf291841e-ccbd-4f5a-b1de-4cf596a167e32017-12-07WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
EBSL-5LIDOCAINE HYDROCHLORIDEWater-Jel Technologies0d2631c1-93fc-478c-afed-0f175a7e85552017-12-07WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
UnburnLIDOCAINE HYDROCHLORIDEWater-Jel Technologies0c504ba8-8a40-43dd-8c68-62ed106b32a22017-12-01WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
UnburnLIDOCAINE HYDROCHLORIDEWater-Jel Technologies40164231-1556-4714-9e27-9d41e3c714472017-11-30WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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