Home Applications 202346 Application 202346
Type ANDA
Sponsor MYLAN TECHNOLOGIES Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LIDOCAINE LIDOCAINE PATCH;TOPICAL 5% 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 A202346-001 LIDOCAINE LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202346-001 AB
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 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202346-001 LIDOCAINE 5% PATCH / TOPICAL AB 2015-08-07 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 26 · 514 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Numbing Cream LIDOCAINE Sainite Trading Shenzhen Co., Ltd. 49fcbe81-34b6-5906-e063-6294a90aa65b 2026-02-04 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE PHOENIX RX LLC 40949067-a5a8-db8c-e063-6294a90af0fb 2026-02-04 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE PAIN RELIEF PATCHES LIDOCAINE WALMART STORES INC b82cfe42-f521-4784-8c60-98481524c5ec 2026-01-29 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE Fougera Pharmaceuticals, LLC 88ca9cba-0c4a-482f-b502-ceefdb1bfbcd 2026-01-28 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE Lidocaine Pain Relief LIDOCAINE Trifecta Pharmaceuticals USA, LLC. 493c09d0-16d7-7413-e063-6394a90aa052 2026-01-26 Warnings Name fallback generic name: LIDOCAINE CVS 9083 Maximum Strength Lidocaine 4 Pain Relief Patch 1ct Large LIDOCAINE CVS PHARMACY, INC 4914965f-1164-e20e-e063-6294a90ac221 2026-01-23 Warnings Name fallback generic name: LIDOCAINE Equate Pain Relieving Cream Lidocaine LIDOCAINE Wal-Mart Stores Inc 52b91508-22aa-4c4b-94f4-977f14a01dad 2026-01-20 Warnings Name fallback generic name: LIDOCAINE Black Cobra Tattoo NumbingSpray 4% Lidocaine LIDOCAINE Foshan Sugar Max Cosmetics CO.,Ltd 3605fcbf-63c8-87b5-e063-6294a90a9c3e 2026-01-19 Warnings Name fallback generic name: LIDOCAINE Black Cobra Tattoo Numbing Cream 4% Lidocaine LIDOCAINE Foshan Sugar Max Cosmetics CO.,Ltd 3605961a-d596-9c4a-e063-6394a90a99dc 2026-01-19 Warnings Name fallback generic name: LIDOCAINE DYNAMO DELAY SAMPLE BOTTLE LIDOCAINE Momentum Management LLC 05370186-1b82-4d0f-9382-b153252c0221 2026-01-19 Warnings Name fallback generic name: LIDOCAINE Aspercreme with Lidocaine LIDOCAINE Chattem, Inc. 7ad8efa9-7031-4cd0-be1d-6dee63091fd1 2026-01-19 Warnings Name fallback generic name: LIDOCAINE TOPCARE PAIN RELIEF PATCHES LIDOCAINE TOPCO ASSOCIATES, LLC fa2f7768-e779-4409-aad3-6c33ce2e6b36 2026-01-18 Warnings Name fallback generic name: LIDOCAINE Aspercreme with Lidocaine XL LIDOCAINE Chattem, Inc. b0859b10-539e-4905-ab52-af78b778d6a4 2026-01-15 Warnings Name fallback generic name: LIDOCAINE Pain Relieving Patch LIDOCAINE FlexiGo Inc. 4868af2a-c4be-9c68-e063-6394a90a565b 2026-01-15 Warnings Name fallback generic name: LIDOCAINE Careland Lidocaine 4 Pain Relieving Gel-Patches LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. a6ca8382-7ce5-4df9-912e-8a0ac0423116 2026-01-15 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE 4% AvKARE 70aace2f-47b4-e961-e053-2991aa0a6367 2026-01-14 Warnings Name fallback brand name: Lidocaine Lidocaine LIDOCAINE AvKARE 0a4cc4f8-9c5d-d03f-e063-6394a90a1b2e 2026-01-14 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE Aspercreme with Lidocaine Essential Oils Rosemary Mint LIDOCAINE Chattem, Inc. 9c81d5eb-fa9b-47fb-8924-6ebf6a5c6bab 2026-01-13 Warnings Name fallback generic name: LIDOCAINE THE SOLUTION 2.0 LIDOCAINE SCALP TECH INC 0fa423b6-cc0f-b569-e063-6294a90a239e 2026-01-09 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE Bellus Medical, LLC 60cb89f6-e326-0773-e053-2a91aa0a33dd 2026-01-09 Warnings Name fallback brand name: Lidocaine generic name: LIDOCAINE
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 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0378-9055 Lidocaine lidocaine Mylan Pharmaceuticals Inc. ANDA Current 0378-9055 Lidocaine lidocaine Mylan Pharmaceuticals Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 57199 ORIG 2019-01-14