Application 088572

Type
ANDA
Sponsor
ABBOTT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PEDIATRIC LTA KITLIDOCAINE HYDROCHLORIDESOLUTION;TOPICAL2%NoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A088572-001PEDIATRIC LTA KITLIDOCAINE HYDROCHLORIDE2%SOLUTION / TOPICAL1984-07-31

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-313f01610625f2…
2019-09-15 20:21 UTC2019-09A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088572-001PEDIATRIC LTA KIT2%SOLUTION / TOPICAL1984-07-31e64feba35796…

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 16 · 302 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Pain Relief Roll-On Lidocaine with LavenderLIDOCAINE HYDROCHLORIDECVS Pharmacy4aa53176-2103-b47b-e063-6394a90ac7352026-08-12WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
LidocaineLIDOCAINE HYDROCHLORIDESentiss Pharmaceuticals LLC9b2d4f69-0c84-4956-b5c0-b4410acf62e02026-08-12Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine Tattoo WipeLIDOCAINE HYDROCHLORIDEMD Tattoo Company369c1d16-597c-e1dc-e063-6394a90a31042026-08-06WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.3b2dd84e-cee8-4e58-d494-395a65a353a02026-08-05Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.9c18eaf1-4a0b-4916-70b2-88a8274947112026-08-05Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEYYBA CORP582a0001-da1e-909a-e063-6394a90a2b112026-08-03WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC46404c7b-2ea4-e47b-e063-6294a90a779f2026-08-03Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Xylocaine MPFLIDOCAINE HYDROCHLORIDESportpharm LLC50aa6133-0776-4714-9821-fe8581f635ca2026-07-28Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Aspercreme Lidocaine with Rosemary and MintLIDOCAINE HYDROCHLORIDEChattem, Inc.9d40bfea-85d0-4943-83e9-0c16e79a011c2026-07-28WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCf8fa72db-5f7a-4158-a2b3-f8bc0e12df9f2026-07-24WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCa32cbc19-ec30-4634-b70d-664f2a2edd952026-07-24WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC573a7298-b02e-230c-e063-6294a90a269c2026-07-22Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.462e9498-9eb9-456a-9022-659bcff93e3f2026-07-17Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Painsil Pain Relief Roll-OnLIDOCAINE HYDROCHLORIDEPainsil LLCdee39dff-5749-4ef2-a9ed-182f25e01f672026-07-14WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHenry Schein, Inc.fa7dedcd-d78b-45f2-9dd7-f273043167d02026-07-14Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
ZyloReliefLIDOCAINE HYDROCHLORIDEHighmark Pharma LLC635f5b98-f74c-495f-a537-686fcba9ccad2026-07-14WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst2177b6fe-aa37-6f6b-e063-6294a90af09a2026-07-10Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
TopCare Health Pain ReliefLIDOCAINE HYDROCHLORIDETopco Associates LLC485b0671-da09-19d7-e063-6294a90aca5d2026-07-03WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
JJ Care BURNLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.d69ebc53-8552-449a-a973-f211328a3d3e2026-07-03WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE
Desert Harvest Releveum with LidocaineLIDOCAINE HYDROCHLORIDEDesert Harvest, Inc9ad514ab-a6bd-4564-8ba3-0149032ebf362026-07-01WarningsName fallback
generic name: LIDOCAINE HYDROCHLORIDE