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 14 of 26 · 514 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join RWWXII Deep Numbing Cream(Anorectal Hemorrhoidal Cream) LIDOCAINE Guangzhou Haishi Biological Technology Co., Ltd. 3ffc57c7-5bf4-cba8-e063-6394a90a322f 2025-09-29 Warnings Name fallback generic name: LIDOCAINE Lidocaine Hydrochloride LIDOCAINE Henry Schein, Inc. 0c0790ec-effd-4d8a-9874-8ca0b31e54d0 2025-09-29 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE Preferred Pharmaceuticals Inc. 2310b6ae-cacf-4b29-9b03-7f42849dfc18 2025-09-22 Warnings Name fallback brand name: Lidocaine generic name: LIDOCAINE Asper Flex LIDOCAINE Akron Pharma Inc. 06ddae64-cda7-4eb9-872f-5182c83cb00c 2025-09-19 Warnings Name fallback generic name: LIDOCAINE Good Neighbor Pain Relief Patch With Lidocaine 4% LIDOCAINE Amerisource Bergen 5f5cc887-d479-4c9a-affc-49d0c331f742 2025-09-18 Warnings Name fallback generic name: LIDOCAINE Burn Ease Cooling LIDOCAINE ProStat First Aid LLC ec201ca1-efa0-4797-aec3-115647c29abd 2025-09-17 Warnings Name fallback generic name: LIDOCAINE JO for Him Prolonger with Lidocaine LIDOCAINE CC Wellness LLC b12dc6a3-142d-3219-e053-2995a90aead0 2025-09-12 Warnings Name fallback generic name: LIDOCAINE PAIN RELIEF PATCHES LIDOCAINE Amerisource Bergen 614f1e56-891f-4620-be10-0c075a1dbc3f 2025-09-11 Warnings Name fallback generic name: LIDOCAINE Bikini Zone Medicated Creme LIDOCAINE Kingsway Pharmaceuticals dba NFI, LLC 300ac57e-844a-4840-b285-41ff5518e6b6 2025-08-29 Warnings Name fallback generic name: LIDOCAINE Bikini Zone Medicated Gel LIDOCAINE Kingsway Pharmaceuticals dba NFI, LLC 30b85890-e72d-4af7-bda9-e7744abc92af 2025-08-29 Warnings Name fallback generic name: LIDOCAINE Sumifun Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 3d7dc8cc-0680-d94d-e063-6394a90ac8e8 2025-08-29 Warnings Name fallback generic name: LIDOCAINE else. LIDOCAINE Else Co. 3d6c7b10-ed03-bbde-e063-6294a90ae92f 2025-08-28 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE Actavis Pharma, Inc. c18799cd-9e11-4196-9ab1-0a2a84585e56 2025-08-26 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE VBBV Anorectal(Hemorrhoidal) Creams LIDOCAINE Jiashen International Trading Co., Ltd. 3cba84ea-5ee0-7ee3-e063-6294a90af11b 2025-08-19 Warnings Name fallback generic name: LIDOCAINE Orythia Maximum Strength Lidocaine Pain Relieving LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. 6d6b59f9-f614-4e3c-b07b-32b4591d39f2 2025-08-18 Warnings Name fallback generic name: LIDOCAINE Ocean Potion Suncare Ice Plus Pain Relieving Soothing LIDOCAINE GNL BRANDS INTERNATIONAL, LLC 3c69654c-cba6-dfef-e063-6394a90ad479 2025-08-15 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE A-S Medication Solutions e23a92e6-3445-4ba7-9ad2-86a3eec1717e 2025-08-15 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE Burn LIDOCAINE HART Health c5ff392a-e788-43e0-91ea-5e0f8420586c 2025-08-15 Warnings Name fallback generic name: LIDOCAINE Signature Care Aloe Vera Gel with Lidocaine LIDOCAINE Safeway, Inc. d5069622-97b1-ba12-e053-2a95a90a7268 2025-08-14 Warnings Name fallback generic name: LIDOCAINE Careland X-large Lidocaine 4 Pain Relieving LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. a6867506-4a46-47b1-b5b6-bfedb59dfde6 2025-08-11 Warnings Name fallback generic name: LIDOCAINE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.