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 24 of 26 · 504 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Prolayed LIDOCAINE MATRIX MIXOLOGY, INC ae317876-adb1-6d13-e053-2995a90a74af 2023-12-01 Warnings Name fallback generic name: LIDOCAINE Bloop Fissure Healing Anorectal Topical LIDOCAINE Three Nations Corp 0b645092-ebc4-e4bb-e063-6294a90ad4cf 2023-11-30 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE Bryant Ranch Prepack 6d7fdc43-e493-449e-9af6-825e584b547a 2023-11-16 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE SIMPLY VITAL HEMORRHOID and ANORECTAL RELIEF LIDOCAINE ALPHA PLANTS INC 79fa4b89-382f-45fa-a792-90a9fe5bf573 2023-11-11 Warnings Name fallback generic name: LIDOCAINE GeriGentle FrostyHeat Pain Relief Patch 4 Lodocaine Back LIDOCAINE Geri-Gentle Corporation e4427928-c063-9ca6-e053-2995a90a1aa1 2023-11-10 Warnings Name fallback generic name: LIDOCAINE DR REAL NUMB Topical Anorectal LIDOCAINE FUZZYLULU LLC 378d8edc-2120-416d-854c-8881c2950efe 2023-11-09 Warnings Name fallback generic name: LIDOCAINE Zcaine Fast Acting Anesthetic LIDOCAINE PHI, Inc d072243f-6ba6-4ab6-8ebf-a2381fa9c2df 2023-11-09 Warnings Name fallback generic name: LIDOCAINE Plum Smooth Plumb Numb Gelee LIDOCAINE Universal Companies, Inc. 6be7d8e0-6cd0-4da2-926f-3dbb3db3bd8e 2023-11-09 Warnings Name fallback generic name: LIDOCAINE Sonacaine Topical Anesthetic With Menthol LIDOCAINE Filltech USA, LLC ca54c6da-4bf2-4e63-ba7f-a69c4f9c431a 2023-11-09 Warnings Name fallback generic name: LIDOCAINE Bed Bug Instant Bite Relief LIDOCAINE P.F. Harris Mfg. Co. LLC 7f472fd0-5605-4cc6-b4b2-1267e815255c 2023-11-09 Warnings Name fallback generic name: LIDOCAINE Brazzers Anal Desensitizing LIDOCAINE Metro Media Ent ceacd80c-0dd6-4e21-97da-56da877b1c90 2023-11-06 Warnings Name fallback generic name: LIDOCAINE NUMB PLUS Maximum Strength Anorectal LIDOCAINE SEENEXT VENTURE LTD a7c37b2a-b647-43d7-b43b-87bbece35430 2023-11-05 Warnings Name fallback generic name: LIDOCAINE LIDOCAINE LIDOCAINE Alembic Pharmaceuticals Inc. 11a8b27a-1e25-46e5-bc23-ae5c894b4da4 2023-10-30 Warnings, Adverse reactions Name fallback brand name: LIDOCAINE generic name: LIDOCAINE MAXIMUM STRENGTH HEMORRHOIDAL RELIEF LIDOCAINE CVS PHARMACY, INC b61424bf-3b23-420b-a7bc-256ddb96aa22 2023-10-25 Warnings Name fallback generic name: LIDOCAINE MAXIMUM STRENGTH HEMORRHOIDAL RELIEF with Finger Cots LIDOCAINE CVS PHARMACY, INC 82aa128a-44cd-4907-b0f7-8a31e086d3e6 2023-10-25 Warnings Name fallback generic name: LIDOCAINE Assured Bikini Smooth Cream LIDOCAINE Zhejiang Jingwei Pharmaceutical Co., Ltd. fb9ddde3-3f40-467e-8aff-26570144f0fc 2023-10-25 Warnings Name fallback generic name: LIDOCAINE Lidocaine 5% LIDOCAINE Apnar Pharma LP ceedce20-5723-5a9a-e053-2a95a90a17a1 2023-10-21 Warnings Name fallback generic name: LIDOCAINE Microcaine Topical Analgesic LIDOCAINE Unit Dose, Ltd. 5e8fa8b5-0524-4201-91e1-83e59a8f0415 2023-10-19 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE Bryant Ranch Prepack 6fe7721d-42b3-4284-936b-a448ca530c45 2023-09-14 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE Lidocaine LIDOCAINE Septodont, Inc. 82a4c16f-d47e-479f-8f85-7d1be6fc2318 2023-07-07 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