Home Applications 080409 Application 080409
Type ANDA
Sponsor HOSPIRA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LTA II KIT LIDOCAINE HYDROCHLORIDE SOLUTION;TOPICAL 4% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A080409-001 LTA II KIT LIDOCAINE HYDROCHLORIDE 4% SOLUTION / TOPICAL Approved 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 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A080409-001 LTA II KIT 4% SOLUTION / TOPICAL Approved before 1982 cb3db0bc1861…
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 9 of 15 · 300 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Eugia US LLC 9916b09d-a116-469d-92d5-60e50ea9782b 2025-02-07 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE TheraCare Pain Relieving Lidocaine Cream LIDOCAINE HYDROCHLORIDE Veridian Healthcare 2d42192b-8889-a896-e063-6294a90a4fc8 2025-02-03 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Eugia US LLC ccc38d8a-43fd-44c0-985e-32af9ed956ab 2025-02-03 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE PAI Holdings, LLC dba PAI Pharma d5e23ede-957c-4a32-b1c6-268acb773c31 2025-01-31 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE INTIMALE LIDOCAINE DELAY LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 5ddd7d56-bf51-462b-afcd-944861e49781 2025-01-28 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Meijer Odor Free Analgesic Pain Relieving Topical Analgesic LIDOCAINE HYDROCHLORIDE Meijer Distribution, Inc 6288efea-f636-4eea-bb9f-78aa2f9af54a 2025-01-14 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE IKONIK TONIK LIDOCAINE HYDROCHLORIDE IKONIK CARE, LLC 122fdfe8-b5fa-46d1-9fd9-3df9887ed320 2025-01-14 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Burn Jel LIDOCAINE HYDROCHLORIDE Water-Jel Technologies ff621b46-2342-41db-994d-851a09796d08 2025-01-06 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine hydrochloride LIDOCAINE HYDROCHLORIDE Advanced Rx Pharmacy of Tennessee, LLC f4c19cf5-c8b1-5e9f-e053-2995a90aee53 2024-12-31 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE HealthWise 4% Lidocaine Cream LIDOCAINE HYDROCHLORIDE Veridian Healthcare 0fb2af30-7f2d-c7c4-e063-6294a90a37f7 2024-12-19 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Viscous LIDOCAINE HYDROCHLORIDE Hikma Pharmaceuticals USA Inc. 79b42076-359d-4258-b1d8-f40e67ac5424 2024-12-17 Boxed warning, Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Serum X LIDOCAINE HYDROCHLORIDE AO Biologix, LLC e07b6268-6400-6849-e053-2a95a90a8b3e 2024-12-11 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE McKesson Corporation dba SKY Packaging 903cd7bd-6c3d-4068-bb24-e91b1ca1393d 2024-12-10 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Bryant Ranch Prepack f581248d-697d-4174-aa42-afdf4ecce02e 2024-12-05 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE PO First Aid Series BURN LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. f1c349a8-216d-4233-922e-c95329a33d1e 2024-12-05 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE TheraCare Pain Relieving Lidocaine Cream LIDOCAINE HYDROCHLORIDE Veridian Healthcare 242204d3-efc7-f7a9-e063-6294a90a5af1 2024-11-27 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE First Aid Only Burn LIDOCAINE HYDROCHLORIDE Acme United Corporation 9af39fcd-0a57-26d0-e053-2a95a90a99a0 2024-11-17 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE XYLOCAINE MPF LIDOCAINE HYDROCHLORIDE HF Acquisition Co LLC, DBA HealthFirst 1986c302-82a0-95a9-e063-6294a90a3339 2024-11-15 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE XYLOCAINE MPF LIDOCAINE HYDROCHLORIDE HF Acquisition Co LLC, DBA HealthFirst 199ac3eb-1fa5-9cf5-e063-6394a90a7228 2024-11-15 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Meijer Pain Relieving Max Strength with Lavender Essential Oil Analgesic LIDOCAINE HYDROCHLORIDE Meijer Distribution, Inc e688967e-799a-4fc8-a19a-f0012b90e76b 2024-11-15 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE