Home Applications 040837 Application 040837
Type ANDA
Sponsor WATSON LABS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE JELLY;TOPICAL 2% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A040837-001 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23
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 · 43 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 2026-09-14 22:38:34 2026-08 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040837-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 2011-03-23 f41ea6bd6efb…
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 16 · 304 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocaine LIDOCAINE HYDROCHLORIDE ARMAS PHARMACEUTICALS INC. 2f6e0f3d-ceaf-a853-e063-6394a90a8efb 2025-03-07 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lightning Products BURN RELIEF LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. 555ac696-e761-4a5a-bed8-945dc64d5be5 2025-02-27 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine LIDOCAINE HYDROCHLORIDE Fresenius Kabi USA, LLC f1b26274-a55e-4321-b96c-ce0df830f205 2025-02-20 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE McKesson Corporation dba SKY Packaging e1eabd6b-9bb8-646f-e053-2a95a90a7b83 2025-02-20 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine hydrochloride LIDOCAINE HYDROCHLORIDE NorthStar RxLLC 6a7fa6c5-b550-46ac-99a3-5c49339e6dbd 2025-02-19 Warnings, Adverse reactions Name fallback brand name: Lidocaine hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Eugia US LLC 9916b09d-a116-469d-92d5-60e50ea9782b 2025-02-07 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride 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 brand name: Lidocaine Hydrochloride 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 brand name: Lidocaine Hydrochloride 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 brand name: Lidocaine hydrochloride 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 brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Bryant Ranch Prepack f581248d-697d-4174-aa42-afdf4ecce02e 2024-12-05 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride 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
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0591-3012 Lidocaine Lidocaine Hydrochloride Actavis Pharma, Inc. ANDA Current 53217-222 Lidocaine Lidocaine Hydrochloride Aidarex Pharmaceuticals LLC ANDA Current 53217-223 Lidocaine Lidocaine Hydrochloride Aidarex Pharmaceuticals LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 42638 ORIG 2013-10-23