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 13 of 16 · 307 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Thera Plus Max Strength Lidocaine Pain Relief LiquidLIDOCAINE HYDROCHLORIDEFourstar Group USA, Inc.0a228b06-0e1c-6c75-e063-6294a90a9a0e2023-11-30WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
IceQuake Lidocaine AnalgesicLIDOCAINE HYDROCHLORIDESouthern Sales & Service, Inc.9089cb78-e9f8-4437-a767-df809a114c4b2023-11-29WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC0a353fe1-b779-3d1f-e063-6294a90ab21b2023-11-15Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
MAXOCAINE Lidocaine Hemp Oil Topical AnalgesicLIDOCAINE HYDROCHLORIDEPrime Commerce, LLC28ed2149-38d2-4062-8442-990a98a69cfc2023-11-11WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
SUGAR BRANDS Rescue Pain Relief and RecoveryLIDOCAINE HYDROCHLORIDESugar Brands, LLC74013709-d1d5-4425-825d-eee726718c612023-11-11WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
NATURES CRAFT LIDOCAINE Male Genital DesensitizerLIDOCAINE HYDROCHLORIDENatures Design Products LLC61bf1776-5c6c-4307-8348-41fa601640172023-11-11WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
KARMA RUB Elemental Pain ReliefLIDOCAINE HYDROCHLORIDEElemental Bliss LLCc224fb1b-827f-461e-a58f-4020700c3e0d2023-11-11WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
INTIMALE Maximum Strength DelayLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED25b9ade3-72b0-4b86-8c48-90310a26806f2023-11-11WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
POWERECT Max Power Male DelayLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED25a1c926-9543-44a7-865e-a4b6e1a40cbe2023-11-11WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
SKINS DELAY Maximum Strength LidocaineLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED172efe5d-28b8-443c-b3f9-4296691890812023-11-11WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
LIDOSOLVE PAIN RELIEFLIDOCAINE HYDROCHLORIDEHENNIKA HEALTH, LLC3a9e4e0c-362d-4e66-bb5f-984fe1c9d4e22023-11-11WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Uber NumbLIDOCAINE HYDROCHLORIDEUBERScientific, LLC65a319a6-89d2-44c9-81d5-30327f9948cb2023-11-10WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Uber NumbLIDOCAINE HYDROCHLORIDEUBERScientific, LLC768f3f0e-1add-404f-b869-00a9f35ad34a2023-11-10WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Uber Numb Topical AnestheticLIDOCAINE HYDROCHLORIDEUberScientific, LLC441c802f-a363-1530-e054-00144ff88e882023-11-10WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Uber Numb Topical AnestheticLIDOCAINE HYDROCHLORIDEUberScientific, LLC4939a547-c94b-3350-e054-00144ff88e882023-11-10WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
DOCTORS TOUCH Erase The Pain LidocaineLIDOCAINE HYDROCHLORIDEDOCTOR'S CHOICE MEDICAL, LLC3dc9947b-8196-4a38-97b4-c2340ee77e0f2023-11-06WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
RadiaGuard Advanced Radiation ReliefLIDOCAINE HYDROCHLORIDESMOOTH SIDE, INC21205087-5a2e-41a5-be40-30cba28954082023-11-06WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
SKINS DELAY Climax Control LidocaineLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED0db91010-12f7-4f20-b96c-432915720d5a2023-11-06WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
POWERECT Lidocaine Male DelayLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED42e0c40f-1efd-45ef-815d-53d193d720eb2023-11-06WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
WAXUP NumbingLIDOCAINE HYDROCHLORIDECONSTRUSOLUTION, LLC4f1645ab-1b19-4d69-99c3-9ea275b01a872023-11-06WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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