Home Applications 216484 Application 216484
Type ANDA
Sponsor ALKEM LABS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LIDOCAINE LIDOCAINE PATCH;TOPICAL 5% 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 A216484-001 LIDOCAINE LIDOCAINE 5% PATCH / TOPICAL AB 2025-10-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216484-001 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 A216484-001 LIDOCAINE 5% PATCH / TOPICAL AB 2025-10-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216484-001 LIDOCAINE 5% PATCH / TOPICAL AB 2025-10-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216484-001 LIDOCAINE 5% PATCH / TOPICAL AB 2025-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216484-001 LIDOCAINE 5% PATCH / TOPICAL AB 2025-10-06 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216484-001 LIDOCAINE 5% PATCH / TOPICAL AB 2025-10-06 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 7 of 26 · 514 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Careland Lidocaine Pain Relieving LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. c4c86a8f-1d57-49d2-a65f-acb0dccf2f87 2026-04-21 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE Macleods Pharmaceuticals Limited c788afd3-4554-40c4-8f26-2c31ab9b9b98 2026-04-16 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE Relivyx Plus LIDOCAINE V2 Pharma LLC 08aeb3f5-56ea-4fd7-b151-e6dc65f202da 2026-04-16 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE Neurocaine LIDOCAINE Blue Heron Pharmaceuticals LLC f36eaded-3155-480c-8723-4b07b6b0790d 2026-04-16 Warnings Name fallback generic name: LIDOCAINE LIDOCAINE LIDOCAINE Preferred Pharmaceuticals, Inc. e7ed90d7-11c0-4781-a727-1fe3659a2948 2026-04-15 Warnings, Adverse reactions Name fallback brand name: LIDOCAINE generic name: LIDOCAINE Walgreens Lidocaine Pain Relieving Patch Assorted LIDOCAINE Walgreen Co. 41e98f15-669f-4543-e063-6294a90a1ef7 2026-04-15 Warnings Name fallback generic name: LIDOCAINE TheraCare Lidocaine Pain Relief LIDOCAINE Veridian Healthcare 4f112ab2-b67a-a3e2-e063-6394a90acb60 2026-04-09 Warnings Name fallback generic name: LIDOCAINE Burn Relief LIDOCAINE CVS Pharmacy, Inc. 42b3c341-f422-b2b4-e063-6294a90a47b2 2026-04-06 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE YYBA Corp 5256a84a-8dac-8fd4-e063-6294a90a616c 2026-04-01 Warnings Name fallback brand name: Lidocaine generic name: LIDOCAINE SPARTAN LIDOCAINE TIV PRIME SRL 4e04146a-ed19-2271-e063-6394a90a50f0 2026-03-27 Warnings Name fallback generic name: LIDOCAINE Walgreens Pain Relieving Lidocaine LIDOCAINE Walgreen Co. 41d5bdc4-66c8-31ab-e063-6394a90a1195 2026-03-27 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE Novocol Pharmaceutical of Canada, Inc. 2005680a-8a23-4403-a618-e4ee74fa1121 2026-03-26 Warnings, Adverse reactions Name fallback brand name: Lidocaine Lidocaine LIDOCAINE YYBA Corp 472fe0d1-31a1-fded-e063-6394a90a4a66 2026-03-25 Warnings Name fallback brand name: Lidocaine generic name: LIDOCAINE EjaGuard LIDOCAINE MOLANSPACE INC 475f64ef-d636-7e87-e063-6294a90ae32f 2026-03-25 Warnings Name fallback generic name: LIDOCAINE LIDOCAINE LIDOCAINE YYBA Corp 4db609cc-f329-62a4-e063-6394a90aefc1 2026-03-23 Warnings Name fallback brand name: LIDOCAINE generic name: LIDOCAINE LIDOCAINE LIDOCAINE DIRECT RX a575bcb8-478f-1f7e-e053-2995a90a4b12 2026-03-17 Warnings, Adverse reactions Name fallback brand name: LIDOCAINE generic name: LIDOCAINE Lidocaine LIDOCAINE Direct_Rx 00725e5b-694c-b9e1-e063-6294a90a4182 2026-03-17 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE Lidocaine LIDOCAINE Direct_rx 29f211ff-dcba-afb0-e063-6294a90afb9b 2026-03-17 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE Crane Safety Burn LIDOCAINE Crane Safety LLC 96d81566-6321-731e-e053-2995a90ad07d 2026-03-16 Warnings Name fallback generic name: LIDOCAINE LIDOCAINE LIDOCAINE DIRECT RX b8663046-67a4-4858-e053-2a95a90a8aed 2026-03-16 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.