FDA.reportPublic FDA data

Application 080406

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION0.01MG/ML;1%NoNo
002LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION0.01MG/ML;2%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
A080406-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDE0.01MG/ML;1%INJECTABLE / INJECTIONRLD, Approved before 1982
A080406-002LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDE0.01MG/ML;2%INJECTABLE / INJECTIONApproved 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.

Product history page 3 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A080406-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONApproved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09A080406-002LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080406-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONApproved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080406-002LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A080406-001LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;1%INJECTABLE / INJECTIONRLD, Approved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A080406-002LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTIONApproved before 1982a50c72e98297…

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 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine Hydrochloride and EpinephrineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINECardinal Health 107, LLC77fd6ee4-108f-4525-8df5-7db9236042ee2026-05-20Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride and Epinephrine
Lidocaine Hydrochloride and EpinephrineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINEHenry Schein, Inc.5569d607-f1cb-4f1d-8a00-d50433ec05d32026-05-07Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride and Epinephrine
Lidocaine Hydrochloride and EpinephrineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINESportpharm LLC2c58deba-dbb2-4e73-a173-36053536f03e2026-04-22Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride and Epinephrine
Lidocaine Hydrochloride and EpinephrineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINEHenry Schein, Inc.c3490a23-14c4-43f7-b066-96a4c4298fde2026-04-14Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride and Epinephrine
Lidocaine Hydrochloride and EpinephrineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINEProPharma Distribution43048b6b-3c83-eef4-e063-6294a90a34cb2025-12-18Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride and Epinephrine
Lidocaine Hydrochloride and EpinephrineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINEHenry Schein, Inc.e0e621d2-10b0-4cdf-b31d-c19b1e86ba6b2025-06-03Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride and Epinephrine

Reported adverse events (FAERS/openFDA)#

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