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 23 of 26 · 514 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Care Science LIDOCAINE ASO LLC 22cbb664-b659-3beb-e063-6394a90a9dab 2024-09-23 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE Stratus Pharmaceuticals Inc e1a8d4a7-01f7-4bab-8d09-875c461b3b61 2024-09-19 Warnings Name fallback brand name: Lidocaine generic name: LIDOCAINE Lidocaine LIDOCAINE Aurobindo Pharma Limited 29199070-6dcb-4086-9a68-49e819965dbd 2024-09-05 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE Careland Max Strength Lidocaine 4 Pain Relieving LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. 265b8dd7-64a4-4bc2-a91c-26c761c2090b 2024-08-21 Warnings Name fallback generic name: LIDOCAINE Theracare Lidocaine Pain relief LIDOCAINE Veridian Healthcare 1d8a3679-637d-94c0-e063-6294a90a9ecf 2024-08-19 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE Bryant Ranch Prepack 4e856dd5-f2fa-4acb-a205-f87baf26b8cc 2024-08-08 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE Bunnies Bum Hemorrhoidal Numbing LIDOCAINE FloCal Distributors LLC 1c809643-0cbe-568f-e063-6394a90a3210 2024-07-05 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE Advanced Rx Pharmacy of Tennessee, LLC 1b561cc6-1d36-e259-e063-6294a90aacbd 2024-06-27 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE PUREGEN LABS Pain Relief 4 Lidocaine LIDOCAINE Advanced Rx LLC 9dff40d8-8d7e-4629-bea5-987f5e68477d 2024-06-11 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE FORREAL PHARMACEUTICALS LLC 14edf7dc-c5dc-4b74-b583-0f87529f4536 2024-06-06 Warnings Name fallback brand name: Lidocaine generic name: LIDOCAINE Lidocaine LIDOCAINE Bryant Ranch Prepack 1d28d687-695e-4cd9-97e2-7d4fdab9772a 2024-06-05 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE PUREGEN LABS Maximum Strength Lidocaine LIDOCAINE Advanced Rx LLC f4f89582-49e6-424a-bea7-0694484a7c99 2024-04-11 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE Bryant Ranch Prepack b4db5684-988f-44c4-a81e-5c04b8b0f6e7 2024-04-05 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE Lidocaine LIDOCAINE Bryant Ranch Prepack 19c585f3-e635-44d4-8eb0-14529eb34dca 2024-04-03 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE Meijer Pain Relief Cream LIDOCAINE Meijer Distribution 07ecee44-387a-cdce-e063-6294a90ab9c9 2024-03-27 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE Safco Dental Supply Co 6721c3ab-c37f-4504-aebc-0103c56ed567 2024-02-08 Warnings, Adverse reactions Name fallback brand name: Lidocaine Leader Burn Relief LIDOCAINE Cardinal Health f4e8e3b7-fd84-bdbc-e053-2a95a90aeab2 2024-02-06 Warnings Name fallback generic name: LIDOCAINE Aspercreme LIDOCAINE Lead Chemical Co. Ltd. 275e1343-deef-424a-a883-5e780083af91 2024-01-25 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE Bryant Ranch Prepack 65cf652c-87f2-43c6-a6f8-e4a83b42ce78 2024-01-24 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE Burn LIDOCAINE HART Health e95ebdac-9789-41c2-97da-2307e4538794 2024-01-18 Warnings Name fallback generic name: LIDOCAINE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.