Home Applications 208822 Application 208822
Type ANDA
Sponsor VITRUVIAS THERAP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LIDOCAINE LIDOCAINE OINTMENT;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 A208822-001 LIDOCAINE LIDOCAINE 5% OINTMENT / TOPICAL 2017-09-25
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.
Product history page 1 of 2 · 43 observed 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 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL 2017-09-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL 2017-09-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL 2017-09-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL 2017-09-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL 2017-09-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL 2017-09-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL 2017-09-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL 2017-09-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL 2017-09-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL 2017-09-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL 2017-09-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL 2017-09-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL 2017-09-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL 2017-09-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL 2017-09-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL 2017-09-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-09-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-09-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-09-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-09-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-09-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-09-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-09-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-09-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-09-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-09-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-09-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-09-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-09-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL 2017-09-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL 2017-09-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL 2017-09-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL 2017-09-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-09-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-09-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-09-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-09-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-09-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-09-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208822-001 LIDOCAINE 5% OINTMENT / TOPICAL AT 2017-09-25 f41ea6bd6efb…
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 22 of 26 · 504 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocaine LIDOCAINE Amneal Pharmaceuticals LLC 1f46bdfd-3a38-49a3-a505-0192790486d0 2024-10-28 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE Walgreens LIDOCAINE WALGREENS 25127f0d-8878-9136-e063-6394a90a9a84 2024-10-22 Warnings Name fallback generic name: LIDOCAINE Fruit of the Earth Sun Town City Aloe Vera After Sun with Lidocaine HCL LIDOCAINE Fruit of the Earth, Inc. c7a833bd-7457-73a3-e053-2a95a90ac53f 2024-10-17 Warnings Name fallback generic name: LIDOCAINE EQUATE Sunburn relief with Aloe After Sun LIDOCAINE Wal-Mart Stores Inc c25e1288-7ac6-41fc-ab65-26c379f288a7 2024-10-16 Warnings Name fallback generic name: LIDOCAINE PAIN RELIEF PATCHES LIDOCAINE Walgreen Company 1a587e6e-88d1-4b01-abad-9a365dc64a4d 2024-10-15 Warnings Name fallback generic name: LIDOCAINE Universal PAIN RELIEF LIDOCAINE Universal Distribution Center LLC b132a4f2-1b1f-4e80-a183-f9add449065f 2024-10-14 Warnings Name fallback generic name: LIDOCAINE CVS Health Lidocaine Pain-Relieving LIDOCAINE NATURAL ESSENTIALS, INC. d07fdffd-bf7c-4950-9b2d-c06d54ef4c55 2024-10-14 Warnings Name fallback generic name: LIDOCAINE Walgreens Sunburn Relief LIDOCAINE WALGREEN COMPANY d5067903-c559-dc6d-e053-2995a90a8ee3 2024-10-14 Warnings Name fallback generic name: LIDOCAINE CVS Health Lidocaine Pain-Relieving LIDOCAINE Natural Essentials, Inc. fc23b2e2-4abc-4119-b8bd-305b4327f1dd 2024-10-09 Warnings Name fallback generic name: LIDOCAINE Flanax Back Pain Relief LIDOCAINE Belmora LLC 46d33346-e582-4af1-b81a-feca7033dceb 2024-10-04 Warnings Name fallback generic name: LIDOCAINE Fast Freeze Lidocaine LIDOCAINE Natural Essentials, Inc. 029bd3fb-1b5b-48e0-b9af-d91d548b5b0f 2024-10-04 Warnings Name fallback generic name: LIDOCAINE FLANAX BACK PAIN RELIEF LIDOCAINE Belmora Llc af4bf57c-f250-4506-83eb-e0f253e96062 2024-10-04 Warnings Name fallback generic name: LIDOCAINE Lido King Lidocaine 4% Pain Relieving Gel-Patch LIDOCAINE Galaxy Bio, Inc. 2243734a-4ea2-a5e5-e063-6294a90aba15 2024-10-01 Warnings Name fallback generic name: LIDOCAINE LIDOCAINE LIDOCAINE Proficient Rx LP c98eeb63-c896-4417-b0ad-66c4a87efeee 2024-10-01 Warnings, Adverse reactions Name fallback brand name: LIDOCAINE generic name: LIDOCAINE 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
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 69680-120 LIDOCAINE LIDOCAINE VITRUVIAS THERAPEUTICS ANDA Current 69680-120 LIDOCAINE LIDOCAINE VITRUVIAS THERAPEUTICS ANDA Current 69680-120 LIDOCAINE LIDOCAINE VITRUVIAS THERAPEUTICS ANDA Current 69680-120 LIDOCAINE LIDOCAINE VITRUVIAS THERAPEUTICS ANDA Current