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 6 of 16 · 304 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Henry Schein, Inc. 335dfa50-56f3-4c02-b713-8eef4e28eb45 2025-11-17 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Launch Medical LIDOCAINE HYDROCHLORIDE Sambria Pharmaceuticals, LLC 293ef514-44c1-43ac-9a81-c30e34ad39e5 2025-11-12 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Tattoo Numbing Cream Co LIDOCAINE HYDROCHLORIDE Sambria Pharmaceuticals, LLC 2a64b3ef-ed2d-49db-996d-f63ffecb5a1e 2025-11-12 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Painless Tattoo Numbing LIDOCAINE HYDROCHLORIDE Sambria Pharmaceuticals, LLC efd3289f-dfb2-487c-a76f-00fe8af414e3 2025-11-12 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Now Numb Numbing Cream LIDOCAINE HYDROCHLORIDE Sambria Pharmaceuticals, LLC fed833f5-4f76-46e8-8ae1-655a9e576f70 2025-11-12 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Painless Tattoo Numbing Cream LIDOCAINE HYDROCHLORIDE Sambria Pharmaceuticals, LLC 852504ec-d4fa-4cae-ba89-7ffb57df8efe 2025-11-12 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Arte Maximum strength Numbing Cream LIDOCAINE HYDROCHLORIDE Sambria Pharmaceuticals, LLC e612a256-3f44-46db-bb6a-e550c2216fdc 2025-11-12 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Hello Sugar LIDOCAINE HYDROCHLORIDE Sambria Pharmaceuticals, LLC 5f30254d-a28f-443d-8729-5c5dde4a0217 2025-11-12 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE TattooNumb LIDOCAINE HYDROCHLORIDE Sambria Pharmaceuticals, LLC d9c4d664-54de-40c2-8836-72b60e6d9ac0 2025-11-12 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE BeardedMoney LIDOCAINE HYDROCHLORIDE Sambria Pharmaceuticals, LLC 35ff688b-75c5-4780-b294-192af780d705 2025-11-12 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE NeuroMed 7 Topical Pain Relief LIDOCAINE HYDROCHLORIDE Sambria Pharmaceuticals, LLC f199f56b-d971-4cf8-834d-babb5c2ff81a 2025-11-12 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE NeuroMed Topical Anesthetic 7 LIDOCAINE HYDROCHLORIDE Sambria Pharmaceuticals 8a2b6b76-6bcc-4f52-b037-e6cbc74f8377 2025-11-12 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE NeuroMed Topical Anesthetic 7 LIDOCAINE HYDROCHLORIDE Sambria Pharmaceuticals 67b25c37-db32-4980-88b0-b07712345939 2025-11-12 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidozall LIDOCAINE HYDROCHLORIDE V2 Pharma LLC 1eb2dfb2-3ad1-488b-aed9-17220e34a10c 2025-11-12 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidozall Plus LIDOCAINE HYDROCHLORIDE V2 Pharma LLC ba3cbb15-f4ed-443e-af43-a758481acb0b 2025-11-12 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE TopCare Pain Relief Maximum Strength LIDOCAINE HYDROCHLORIDE TOPCO ASSOCIATES b0ae3a7c-52d1-4923-bd50-6bb3749006c8 2025-11-11 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Eugia US LLC 5524cbfd-d6e6-42eb-aaa5-22495e0a86b6 2025-11-11 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE GuruNanda Pain Relief LIDOCAINE HYDROCHLORIDE GuruNanda, LLC. 3ab6a133-8dca-e14e-e063-6394a90a85e7 2025-11-10 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Xylocaine LIDOCAINE HYDROCHLORIDE Henry Schein, Inc. ffc87dfb-0e26-4b42-80fd-3fb7690119e3 2025-11-07 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine hydrochloride LIDOCAINE HYDROCHLORIDE A-S Medication Solutions e67dee40-b243-4d6b-bc6b-e52c6cb798b8 2025-11-01 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Lidocaine hydrochloride 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