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 13 of 26 · 514 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocaine 4% Maximum OTC Strength LIDOCAINE Cardinal Health 107, LLC 975031df-d46d-4098-b1c0-1c0c92b41995 2025-10-20 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE PHOENIX RX LLC 3c69e03c-e176-2c23-e063-6394a90aa41f 2025-10-17 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE Xesso Strawberry Rear Comfort Glide 4% Lidocaine LIDOCAINE Premium Natural Cosmetics Inc efba09fc-6dd7-0f73-e053-2995a90a628a 2025-10-17 Warnings Name fallback generic name: LIDOCAINE lidocaine LIDOCAINE Advanced Rx of Tennessee, LLC 4134f30d-5cb0-e14b-e063-6394a90a4523 2025-10-15 Warnings, Adverse reactions Name fallback brand name: lidocaine generic name: LIDOCAINE Tridacaine III LIDOCAINE Trifluent Pharma LLC 9b47102e-3b35-4aa7-a380-cd02ba9eac65 2025-10-13 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE Tridacaine XL LIDOCAINE Trifluent Pharma LLC 032b37a7-8a47-4809-a330-c76314225cbd 2025-10-13 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE Lidocaine Pain Relieving Gel-Patch LIDOCAINE Nanjing Anxing Medical Technology Co., Ltd. 40c9b132-57ce-865e-e063-6394a90a2080 2025-10-10 Warnings Name fallback generic name: LIDOCAINE Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream LIDOCAINE Guangzhou Haishi Biological Technology Co., Ltd. 40b0e8d6-4686-960b-e063-6294a90a016e 2025-10-09 Warnings Name fallback generic name: LIDOCAINE Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream LIDOCAINE Guangzhou Haishi Biological Technology Co., Ltd. 40b452a3-76b7-2433-e063-6294a90ab6b4 2025-10-09 Warnings Name fallback generic name: LIDOCAINE Pain free IV LIDOCAINE Sambria Pharmaceuticals, LLC 7aa4cb20-d452-417f-afdb-307df754ed75 2025-10-07 Warnings Name fallback generic name: LIDOCAINE SINSINPAS LIDOCAINE PAIN RELIEVING LIDOCAINE Sinsin Pharmaceutical Co., Ltd. 82c0a036-8750-5b3d-e053-2a91aa0a1815 2025-10-07 Warnings Name fallback generic name: LIDOCAINE Lidocanna LIDOCAINE PHARMACURE LLC b28ebbb6-1112-4750-a2bb-f96b03fabe6e 2025-10-06 Warnings Name fallback generic name: LIDOCAINE LIDOCAINE LIDOCAINE PHARMACURE LLC 31d5e5c9-6ec4-4496-8a4c-cca39a2cbe32 2025-10-06 Warnings Name fallback brand name: LIDOCAINE generic name: LIDOCAINE BONDLIDO LIDOCAINE MEDRx USA, Inc. 17e69028-d2c2-4080-8090-cb0cab570196 2025-10-06 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE DYNAMO DELAY LIDOCAINE Momentum Management LLC 2ad63160-4f6f-4970-80b6-f6d19c5660a5 2025-10-03 Warnings Name fallback generic name: LIDOCAINE PROSTAT FIRST AID Burn Ease, 0.9g LIDOCAINE ProStat First Aid LLC dc704403-e2aa-47f7-a7f4-f6afe1547ca8 2025-10-01 Warnings Name fallback generic name: LIDOCAINE PROSTAT FIRST AID Burn Ease, 0.9g LIDOCAINE ProStat First Aid LLC e02558a9-fe2b-4f28-9fd3-7308f859d759 2025-10-01 Warnings Name fallback generic name: LIDOCAINE FL Burn Ease, 0.9g LIDOCAINE ProStat First Aid LLC 4dc0d579-ab42-4ea5-9788-5e54d7d318a3 2025-10-01 Warnings Name fallback generic name: LIDOCAINE Tylenol Precise Pain Relieving Lidocaine 4% LIDOCAINE Kenvue Brands LLC 36a95afd-97e5-2271-e063-6394a90aea18 2025-09-30 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE PHOENIX RX LLC 3ff29d56-8f20-6376-e063-6294a90a667b 2025-09-29 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.