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 11 of 26 · 514 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HealthWise Maximum Pain Relief LIDOCAINE Veridian Healthcare afc3c16d-0076-44b2-ae7e-5f36d4d8088e 2025-12-17 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE, MENTHOL Vive Health LLC 462d3b24-643e-91da-e063-6394a90a0e1d 2025-12-17 Warnings Name fallback brand name: Lidocaine Lidocaine LIDOCAINE PureTek Corporation 85e72943-6989-42f4-b519-a3ebbf4bc777 2025-12-12 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE Pain Relief Gel-Patch LIDOCAINE KORVIA GLOBAL Inc. 45ccfcae-a307-1c5f-e063-6294a90acf89 2025-12-12 Warnings Name fallback generic name: LIDOCAINE Cinthera LIDOCAINE Strand Health Group 2746e5b2-be2d-f2d2-e063-6394a90a3690 2025-12-11 Warnings Name fallback generic name: LIDOCAINE LMX4 LIDOCAINE Ferndale Laboratories, Inc. f0e7c92f-8b0b-4045-b659-af9f6e81260f 2025-12-10 Warnings Name fallback generic name: LIDOCAINE LMX5 LIDOCAINE Ferndale Laboratories, Inc. 34f8ed6b-4a52-4a99-9c1b-254196dc29b0 2025-12-10 Warnings Name fallback generic name: LIDOCAINE Pain and Itch Relief 4% Lidocaine LIDOCAINE Walgreens f84e76a9-6af6-4fd1-be4e-efa05728cbfd 2025-12-09 Warnings Name fallback generic name: LIDOCAINE Leader PAIN RELIEF PATCHES LIDOCAINE Cardinal Health, 110 dba LEADER 5feae39e-3ab8-4cda-b9e8-dc221aea2417 2025-12-08 Warnings Name fallback generic name: LIDOCAINE Leader PAIN RELIEF PATCHES LIDOCAINE Cardinal Health, 110 dba LEADER 3be6defd-f429-4dc7-8b37-5910705c0b81 2025-12-08 Warnings Name fallback generic name: LIDOCAINE LidaFlex LIDOCAINE SOLA Pharmaceuticals b9e49529-13b4-1b0b-e053-2995a90adc7a 2025-12-08 Warnings Name fallback generic name: LIDOCAINE Curist Lidocaine Maximum Strength LIDOCAINE Little Pharma, Inc. d656135a-96da-1245-e053-2a95a90ac626 2025-12-08 Warnings Name fallback generic name: LIDOCAINE Curist Hemorrhoid Relief LIDOCAINE Little Pharma, Inc. d609e1b5-81f0-da12-e053-2a95a90aa847 2025-12-08 Warnings Name fallback generic name: LIDOCAINE Lidocaine Patch LIDOCAINE Shenzhen Finona Information Technology Co., Ltd 38767081-7011-6602-e063-6394a90a2784 2025-12-03 Warnings Name fallback generic name: LIDOCAINE 4% Lidocaine Maximum Strength Pain Relief LIDOCAINE Shenzhen Finona Information Technology Co., Ltd 3e5a5165-a773-0501-e063-6294a90ae2f4 2025-12-03 Warnings Name fallback generic name: LIDOCAINE Maximum Strength 4% Lidocaine Patch Good Neighbor Pharmacy LIDOCAINE InterMed Laboratories Private Limited 43f3d189-f6b7-02ed-e063-6394a90afd73 2025-11-19 Warnings Name fallback generic name: LIDOCAINE Maximum Strength 4% Lidocaine Patch HealthA2Z LIDOCAINE InterMed Laboratories Private Limited 43f3e288-e828-8130-e063-6394a90a6d44 2025-11-19 Warnings Name fallback generic name: LIDOCAINE Maximum Strength 4% Lidocaine Patch Leader LIDOCAINE InterMed Laboratories Private Limited 42f06914-c8b8-ea9c-e063-6294a90a79e6 2025-11-19 Warnings Name fallback generic name: LIDOCAINE Pain Relieving Lidocaine Patch LIDOCAINE InterMed Laboratories Private Limited 01d3b2bb-3944-083e-e063-6394a90a7816 2025-11-18 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE Preferred Pharmaceuticals Inc. 851844f5-912d-4598-84f3-c0277968b5f1 2025-11-17 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.