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# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 4 of 15 · 300 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ALOE ICE SUNBURN RELIEF LIDOCAINE HYDROCHLORIDE Aloe Care International, LLC 56866fa8-052e-497c-a954-978d7d628949 2026-01-28 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Chartwell RX, LLC c05f49a2-7512-48e7-9730-f8ee05519b9d 2026-01-25 Boxed warning, Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Chartwell Governmental & Specialty RX, LLC. f79b8b30-67ed-4daa-8233-ee2319592ef0 2026-01-25 Boxed warning, Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ProPharma Distribution 48c18a90-9d53-d200-e063-6394a90a1271 2026-01-19 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Viscous LIDOCAINE HYDROCHLORIDE REMEDYREPACK INC. 6f8d20d2-6a91-4a5b-bfe8-f1baada38442 2026-01-16 Boxed warning, Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE CVS Lidocaine Pain Relief Cream LIDOCAINE HYDROCHLORIDE CVS Pharmacy 45c4f946-13b9-7a0a-e063-6394a90a7353 2026-01-16 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Hospira, Inc. 3b2dd84e-cee8-4e58-d494-395a65a353a0 2026-01-16 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Gold Bond Medicated Pain and Itch Relief LIDOCAINE HYDROCHLORIDE Chattem, Inc. 5767362c-83af-494e-a815-a13f2cb093ef 2026-01-14 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Aspercreme Lidocaine Foot (Diabetic) LIDOCAINE HYDROCHLORIDE Chattem, Inc. 2c33d15e-5032-46d9-bd98-5abc7df3bbe5 2026-01-13 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride LIDOCAINE HYDROCHLORIDE Avenacy, LLC 46480253-29b9-4d7f-98ed-10377929026b 2026-01-13 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE LidoPlus Pain Relief LIDOCAINE HYDROCHLORIDE Centura Pharmaceuticals, Inc 07bacc6c-60a6-4297-8663-904a22bdc040 2026-01-12 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE BLACK LABEL B NUMB LIDOCAINE HYDROCHLORIDE SCALP TECH INC 11fcf401-0891-04bc-e063-6294a90a8ad5 2026-01-09 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE 0.5% LIDOCAINE BURN RELIEF LIDOCAINE HYDROCHLORIDE Universal Distribution Center LLC 0a1aeff0-bade-457b-a0ac-099d646c0b2e 2026-01-08 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE 2.0% LIDOCAINE BURN LIDOCAINE HYDROCHLORIDE Universal Distribution Center LLC e1911279-85f7-4053-b6da-8f4e991347a2 2026-01-08 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Precision Dose, Inc. 27b6ef54-a093-2bef-e063-6394a90a7912 2025-12-29 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE WALGREENS BURN LIDOCAINE HYDROCHLORIDE WALGREENS b61e6d73-4f41-ef50-e053-2a95a90a0fc6 2025-12-29 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Aspercreme with Lidocaine Foot Pain Creme LIDOCAINE HYDROCHLORIDE Chattem, Inc. da82cc0e-cc39-408e-87e1-c35bb6f9f51e 2025-12-19 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ProPharma Distribution 38560997-cfe4-2f9b-e063-6394a90a834b 2025-12-18 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ProPharma Distribution 3f2c33e5-290e-2f89-e063-6394a90aee69 2025-12-18 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ProPharma Distribution 42caf92e-6fa9-5bd7-e063-6294a90a3904 2025-12-18 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE