FDA.reportPublic FDA data

Application 080504

Type
ANDA
Sponsor
BELMORA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION2%NoNo
004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION0.01MG/ML;2%NoNo
005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION0.02MG/ML;2%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A080504-001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 1982
A080504-004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDE0.01MG/ML;2%INJECTABLE / INJECTION1983-10-19
A080504-005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDE0.02MG/ML;2%INJECTABLE / INJECTION1983-10-19

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 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A080504-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A080504-004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTION1983-10-19caaa826d4ba7…
2026-08-18 06:07:402026-07A080504-005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTION1983-10-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A080504-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A080504-004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTION1983-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A080504-005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTION1983-10-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080504-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080504-004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTION1983-10-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080504-005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTION1983-10-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A080504-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A080504-004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTION1983-10-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A080504-005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTION1983-10-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080504-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080504-004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTION1983-10-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080504-005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTION1983-10-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080504-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080504-004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTION1983-10-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080504-005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTION1983-10-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080504-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080504-004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTION1983-10-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080504-005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTION1983-10-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080504-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080504-004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTION1983-10-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080504-005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTION1983-10-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080504-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080504-004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTION1983-10-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080504-005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTION1983-10-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080504-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080504-004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTION1983-10-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080504-005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTION1983-10-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080504-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A080504-004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTION1983-10-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A080504-005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTION1983-10-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080504-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080504-004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTION1983-10-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080504-005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTION1983-10-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080504-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080504-004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.01MG/ML;2%INJECTABLE / INJECTION1983-10-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080504-005LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE0.02MG/ML;2%INJECTABLE / INJECTION1983-10-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080504-001LIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONApproved before 19821e350fbaab3a…

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 2 of 16 · 308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHenry Schein, Inc.cfbca641-aeee-4dc8-a340-30c53d3b023b2026-07-01Warnings, Adverse reactionsName fallback
brand name: LIDOCAINE HYDROCHLORIDE
generic name: LIDOCAINE HYDROCHLORIDE
Lidozall ProLIDOCAINE HYDROCHLORIDEV2 Pharma LLCecc26ba7-4ff6-43e6-bfb9-91a9cbb509ff2026-06-16WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDECivica, Inc.3c3b3888-fad3-440b-b627-6f79a2f4668f2026-06-10Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
HealthWise Pain Relief Cream with LidocaineLIDOCAINE HYDROCHLORIDEVeridian Healthcareef176d33-10b9-ddb2-e053-2995a90a76e32026-06-10WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ad1ef0a8-88db-4648-c098-d009eaeb4e5b2026-06-09Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
Aspercreme with Lidocaine No-Mess ApplicatorLIDOCAINE HYDROCHLORIDEChattem, Inc.8092cde7-28d0-4755-b5c0-5765934e572f2026-05-29WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESportpharm LLC5b74b6f4-f26f-4243-8060-cd17779079842026-05-25Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.89a4bd73-89f4-4fd7-2c9f-921e1da8f96b2026-05-22Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.55aa77b8-7601-4432-8631-bfec58daf2472026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lidocaine hydrochloride
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
brand name: Lidocaine Hydrochloride
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
brand name: Lidocaine Hydrochloride
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
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEBryant Ranch Prepack850bdb6a-85d9-441d-8666-7a61311386b62026-04-23Warnings, Adverse reactionsName fallback
brand name: Lidocaine Hydrochloride
generic name: LIDOCAINE HYDROCHLORIDE
LidocaineLIDOCAINE HYDROCHLORIDESportpharm LLC7adb9ab0-ef91-4c51-baa3-a0b7e12df0772026-04-21Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE