Home Applications 217221 Application 217221
Type ANDA
Sponsor DIFGEN PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LIDOCAINE LIDOCAINE PATCH;TOPICAL 1.8% 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 A217221-001 LIDOCAINE LIDOCAINE 1.8% PATCH / TOPICAL AB 2025-03-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217221-001 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.
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 A217221-001 LIDOCAINE 1.8% PATCH / TOPICAL AB 2025-03-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217221-001 LIDOCAINE 1.8% PATCH / TOPICAL AB 2025-03-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217221-001 LIDOCAINE 1.8% PATCH / TOPICAL AB 2025-03-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217221-001 LIDOCAINE 1.8% PATCH / TOPICAL AB 2025-03-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217221-001 LIDOCAINE 1.8% PATCH / TOPICAL AB 2025-03-25 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217221-001 LIDOCAINE 1.8% PATCH / TOPICAL AB 2025-03-25 a50c72e98297…
Observed Orange Book normalized TE history# 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 18 of 26 · 514 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 brand name: Lidocaine Curist Hemorrhoid Fissure Relief LIDOCAINE Little Pharma, Inc 2fb02b00-acdb-5184-e063-6294a90ae1c8 2025-03-06 Warnings Name fallback generic name: LIDOCAINE 5% Dr.care Numb cream LIDOCAINE Shengnan (Guangzhou) Cosmetics Co., LTD 2f905d76-ef9c-c844-e063-6394a90a4dc9 2025-03-04 Warnings Name fallback generic name: LIDOCAINE Maximum strength Lidocaine Patch LIDOCAINE InterMed Laboratories Private Limited 83befa6f-d127-4124-9d1f-44a723eec908 2025-03-01 Warnings Name fallback generic name: LIDOCAINE Numbskin Maximum Strength Pain Reliever LIDOCAINE Shinpharma Inc 2f288bde-99fd-42f8-e063-6394a90a0f05 2025-02-27 Warnings Name fallback generic name: LIDOCAINE Tattoo numbing cream LIDOCAINE BLOOMWELL GARDENS LLC 2ea9d34e-408d-f8d6-e063-6394a90a72a4 2025-02-26 Warnings Name fallback generic name: LIDOCAINE 5% Signature Numb cream LIDOCAINE Shengnan (Guangzhou) Cosmetics Co., LTD 2f043d3c-d8db-414e-e063-6394a90a13de 2025-02-25 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE HYDROCHLORIDE Fresenius Kabi USA, LLC f1b26274-a55e-4321-b96c-ce0df830f205 2025-02-20 Warnings, Adverse reactions Name fallback brand name: Lidocaine Arthcal 4% Lidocaine Gel Patches LIDOCAINE Beijing JUNGE Technology Co., Ltd. 2e6278bb-ca55-70ff-e063-6294a90a6a58 2025-02-17 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE REMEDYREPACK INC. 94ab1b99-e203-4a14-b852-42d3b37999c3 2025-02-14 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE Lidocaine LIDOCAINE NuCare Pharmaceuticals, Inc. 2e0f4ca3-874a-f0d0-e063-6294a90a0b65 2025-02-13 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE Signature Care Medicated Pain Relief Patch LIDOCAINE Safeway, Inc. 2165a342-5f8b-78e0-e063-6394a90a06c4 2025-02-12 Warnings Name fallback generic name: LIDOCAINE LIDOCAINE LIDOCAINE Alembic Pharmaceuticals Limited 071b2cfd-07ad-46a3-8808-87080d545fd3 2025-02-11 Warnings, Adverse reactions Name fallback brand name: LIDOCAINE generic name: LIDOCAINE AsperFlex LIDOCAINE Akron Pharma Inc. ab50525e-b534-452b-8c25-2992c0cbf862 2025-02-10 Warnings Name fallback generic name: LIDOCAINE Lidocore LIDOCAINE iON Pharma, LLC 204c3e50-1ac8-f442-e063-6294a90ae7b5 2025-02-05 Warnings Name fallback generic name: LIDOCAINE lidocaine LIDOCAINE Nivagen Pharmaceuticals, Inc. 32964ec3-1880-477b-9f71-2222c39106aa 2025-01-23 Warnings Name fallback brand name: lidocaine generic name: LIDOCAINE Lidocaine LIDOCAINE Direct_Rx fd8a640a-b5ca-f0a7-e053-6394a90ad603 2025-01-22 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE Lidocaine LIDOCAINE Direct_Rx feb8692a-9c08-0d5c-e053-6394a90a904b 2025-01-22 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE LIDOCAINE LIDOCAINE PHARMACURE LLC 53384c51-6da1-4fa4-8782-2606ca3d1c6f 2025-01-22 Warnings Name fallback brand name: LIDOCAINE generic name: LIDOCAINE Care Science LIDOCAINE ASO LLC 2c399fec-bce7-2a41-e063-6294a90a0e73 2025-01-21 Warnings Name fallback generic name: LIDOCAINE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.