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 10 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 Acme United Corporation f1f051ad-7e82-9d1a-e053-2a95a90ac7d3 2024-11-12 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE STING MASTER LIDOCAINE HYDROCHLORIDE Les Technologies Ptero, Inc 94c6fd1f-9e74-420b-9d25-61b37953b838 2024-11-05 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Alocane Emergency Burn LIDOCAINE HYDROCHLORIDE Quest Products, LLC. 0c8e65a6-dff3-43b4-a3f1-95deb574ea89 2024-11-05 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Alocane Botanicals LIDOCAINE HYDROCHLORIDE Quest Products, LLC. 02a8e5c7-56f4-eb0d-e063-6294a90a80cd 2024-11-05 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Alocane Emergency Burn Pads LIDOCAINE HYDROCHLORIDE Quest Products, Inc. fe58bb89-7216-4121-afd3-d1438bdfbfa2 2024-11-05 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE TopCare Pain Relieving Analgesic LIDOCAINE HYDROCHLORIDE Topco Associates LLC 6b4783e0-1987-4838-9e8c-b95426d62b28 2024-11-05 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Walgreens Pain Relieving with Lavender Analgesic LIDOCAINE HYDROCHLORIDE Walgreen Company 6c7b39c8-5b65-430a-a529-5b6b14adce18 2024-10-31 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Walgreens Pain Relieving with Turmeric Analgesic LIDOCAINE HYDROCHLORIDE Walgreen Company 317ec4fb-cff0-461d-9ca0-299527a3686d 2024-10-30 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Fruit of the Earth Cool Blue Aloe Mist Continuous LIDOCAINE HYDROCHLORIDE Fruit Of The Earth, Inc. d4caae4c-efba-2453-e053-2995a90a5e5f 2024-10-18 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Wegmans Aloe After Sun Gel with Lidocaine HCl External Analgesic LIDOCAINE HYDROCHLORIDE WEGMANS FOOD MARKETS INC f70bc438-7ed8-f74d-e053-6394a90a2b3f 2024-10-16 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE TopCare Everyday After Sun Cooling LIDOCAINE HYDROCHLORIDE TOPCO ASSOCIATES LLC baff7293-e1a3-d1f2-e053-2995a90a93ca 2024-10-15 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Walgreens Cooling LIDOCAINE HYDROCHLORIDE WALGREEN COMPANY baffb272-436c-4ad8-e053-2a95a90a56fb 2024-10-14 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Walgreens Sunburn Relief LIDOCAINE HYDROCHLORIDE WALGREEN COMPANY d4c9913d-fcac-4785-e053-2995a90a7917 2024-10-14 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE SYREN Intimate Relief LIDOCAINE HYDROCHLORIDE Icon Health Science 57d5a080-3583-4510-e053-2a91aa0ad589 2024-09-25 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Theraworx PM Nighttime Maximum Strength Pain Relief LIDOCAINE HYDROCHLORIDE AVADIM HOLDINGS, INC. bc8cb476-9a47-47b3-ad78-a6ecec9ee66f 2024-09-19 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Eugia US LLC ef782e5e-e2d7-465a-99c6-b12611f3158c 2024-09-12 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Meijer Analgesic Lidocaine Topical Analgesic LIDOCAINE HYDROCHLORIDE Meijer Distribution, Inc f5d39be6-3b91-4ba1-9015-fd3ffbbdf4aa 2024-09-12 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Accucaine LIDOCAINE HYDROCHLORIDE Advanced Rx Pharmacy of Tennessee, LLC 01679d29-a592-8cbb-e063-6394a90ad82a 2024-09-11 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Lifestar Pharma LLC 9cb98fb0-5204-4973-8be7-f44ddbfde2ab 2024-09-03 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Wildman Business Group 1fd1a4b3-b6fd-0d4c-e063-6394a90a3680 2024-09-01 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE