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 21 of 26 · 504 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DermacinRx PHN Pak LIDOCAINE PureTek Corporation 8d97cb4b-ca51-49a0-b80e-701c1ca6f438 2024-12-06 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE POMG PAIN RELIEF BODY LIDOCAINE POMG LLC 28d7ac46-b27f-43bb-e063-6294a90a93ed 2024-12-06 Warnings Name fallback generic name: LIDOCAINE Hempvana Ultra Strength Pain Relief - Overnight LIDOCAINE Telebrands Corp 1030d478-6805-6579-e063-6294a90a0c76 2024-12-02 Warnings Name fallback generic name: LIDOCAINE Zensa LIDOCAINE Alera Skin Care Products Inc. f56146b6-3c11-4608-a6ab-6142f27e9ac3 2024-11-24 Warnings Name fallback generic name: LIDOCAINE Signature Care Lidocaine Cream LIDOCAINE Better Living Brands LLC 5483729e-ef1a-47a2-b7cf-c19744f52073 2024-11-21 Warnings Name fallback generic name: LIDOCAINE Hemorrhoid Pain Relief LIDOCAINE Telebrands Corp 04164425-ca3b-ef24-e063-6294a90a59d8 2024-11-20 Warnings Name fallback generic name: LIDOCAINE Hempvana Maximum Strength Pain Relief Topical Anesthetic LIDOCAINE Telebrands Corp f525075a-d7ee-dad0-e053-2a95a90a6f3f 2024-11-20 Warnings Name fallback generic name: LIDOCAINE Hempvana Ultra Strength Pain Relief LIDOCAINE TELEBRANDS CORP d91ba9b1-083f-32e9-e053-2a95a90a9bd1 2024-11-20 Warnings Name fallback generic name: LIDOCAINE Curist Lidocaine Numbing Relief LIDOCAINE Little Pharma, Inc. bff3c422-a0df-6196-e053-2a95a90af033 2024-11-20 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE Patrin Pharma Inc. 91eedf9d-53b8-49d5-af59-25019606a0b2 2024-11-15 Warnings Name fallback brand name: Lidocaine generic name: LIDOCAINE Tylenol Precise Warming Pain Relieving LIDOCAINE Kenvue Brands LLC 0c60b607-ade9-68f2-e063-6394a90a4025 2024-11-13 Warnings Name fallback generic name: LIDOCAINE Tylenol Precise Pain Relieving LIDOCAINE Kenvue Brands LLC fc1e0451-8c84-729e-e053-6394a90aaba0 2024-11-13 Warnings Name fallback generic name: LIDOCAINE Lidocaine Anorectal LIDOCAINE Patrin Pharma, Inc 456d41fe-8449-4980-9291-d7a3b65a900d 2024-11-13 Warnings Name fallback generic name: LIDOCAINE Pain Relieving Gel-Patch LIDOCAINE Shanghai Chuangshi Medical Technology (Group) Co., Ltd. 26c7116f-c86d-8752-e063-6294a90ab73f 2024-11-12 Warnings Name fallback generic name: LIDOCAINE CVS Health Lidocaine Cream LIDOCAINE CVS Health ad950680-c03c-4fa5-aa7f-239a889cd097 2024-11-12 Warnings Name fallback generic name: LIDOCAINE BENGAY Tropical Jasmine LIDOCAINE Kenvue Brands LLC c416320a-c0d7-401e-b0fa-44114d76a557 2024-11-06 Warnings Name fallback generic name: LIDOCAINE Ztlido LIDOCAINE Scilex Pharmaceuticals Inc. a1b17507-4560-490d-a388-74e7fd7eaa5e 2024-11-01 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE LIDOCAINE LIDOCAINE STRATUS PHARMACEUTICALS INC 87a4f559-a4f6-4b9f-98de-b55b073a11c6 2024-11-01 Warnings Name fallback brand name: LIDOCAINE generic name: LIDOCAINE lidocaine LIDOCAINE Advanced Rx of Tennessee, LLC 259f7b21-98c7-3b41-e063-6294a90a34fa 2024-10-29 Warnings, Adverse reactions Name fallback brand name: lidocaine generic name: LIDOCAINE LIDOCAINE LIDOCAINE Advanced Rx of Tennessee, LLC 259f3f4b-50d0-066c-e063-6394a90a2a1e 2024-10-29 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.
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