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 3 of 15 · 300 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Satohap Lidocaine Hydrochloride 4 Percent Pain Relieving LIDOCAINE HYDROCHLORIDE Sato Pharmaceutical Co., Ltd. f7faddb2-5153-4fdd-a5ef-778182cef460 2026-03-31 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Keeps Climax Delay LIDOCAINE HYDROCHLORIDE Cosco International, Inc. 3bfd3173-2dac-40a9-aec3-982b1d47d8fa 2026-03-12 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE CVS Foot Pain LIDOCAINE HYDROCHLORIDE CVS Pharmacy 4c3350c3-2e3e-093c-e063-6394a90a3475 2026-03-04 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Icy Hot Lidocaine No-Mess LIDOCAINE HYDROCHLORIDE Chattem, Inc. 347f9a18-8ab6-47d3-9610-5b4e9ca5d53a 2026-03-02 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Gold Bond Maximum Strength Foot Pain Relief LIDOCAINE HYDROCHLORIDE Gold Bond Co LLC 8e469076-2f5a-4de8-8d13-a38c072b9af8 2026-03-01 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE HealthWise Pain Relief Lidocaine LIDOCAINE HYDROCHLORIDE Veridian Healthcare 48ecbab9-13e0-d0fa-e063-6294a90a6ff2 2026-02-28 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Pain Relieving Gel LIDOCAINE HYDROCHLORIDE Chain Drug Marketing Association b55b7253-2fd2-45cc-b94c-e92395ab0d2b 2026-02-27 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE 0.5% LIDOCAINE BURN RELIEF LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. cf723c7b-495d-4bae-942c-561cf28af2d3 2026-02-21 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride and Dextrose LIDOCAINE HYDROCHLORIDE Baxter Healthcare Corporation f21512ea-c7c3-4766-b976-b2c0b5616bf0 2026-02-20 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine hydrochloride LIDOCAINE HYDROCHLORIDE Advagen Pharma Ltd ae40021b-8df8-4b16-aac0-dcec88f76c7d 2026-02-18 Boxed warning, Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE CVS Pain Relief Roll-On Lidocaine with Lavender LIDOCAINE HYDROCHLORIDE CVS Pharmacy 4aa53176-2103-b47b-e063-6394a90ac735 2026-02-12 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride 2% LIDOCAINE HYDROCHLORIDE Aldermed Inc. 4977b722-d08d-3d9e-e063-6294a90a9035 2026-02-12 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Anthea Pharma Private Limited 240c4744-e58c-4c08-93ad-8d6418c4f8a9 2026-02-11 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Eugia US LLC 89701fac-7536-4f16-87fb-f4cc121e74ee 2026-02-11 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE 2.0% LIDOCAINE BURN LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. 2b58058a-f350-4029-b039-117caf1c0373 2026-02-05 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE glydo LIDOCAINE HYDROCHLORIDE Sagent Pharmaceuticals 65760723-75cd-472c-96e1-7d05f95b4686 2026-02-04 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Sportpharm LLC 415a29c1-101a-4ac2-9ba9-b419a1ce5600 2026-02-03 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Xylocaine LIDOCAINE HYDROCHLORIDE Sportpharm LLC 94155012-b1fc-430a-a1f5-30c21f4a3f80 2026-02-03 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE 5Kind Maximum Strength Pain Relieving Lidocaine HCl Hemp LIDOCAINE HYDROCHLORIDE 5Kind Trading LTD c2df4c90-2b9e-460a-8f54-5d824b484163 2026-01-28 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE VonaFlex Effective Pain Relief Topical Analgesic LIDOCAINE HYDROCHLORIDE OPTIMAL LABORATORIES, LLC 0901244a-7d41-413a-b424-92a807532f28 2026-01-28 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE