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 23 of 26 · 504 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bunnies Bum Hemorrhoidal Numbing LIDOCAINE FloCal Distributors LLC 1c809643-0cbe-568f-e063-6394a90a3210 2024-07-05 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE Advanced Rx Pharmacy of Tennessee, LLC 1b561cc6-1d36-e259-e063-6294a90aacbd 2024-06-27 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE PUREGEN LABS Pain Relief 4 Lidocaine LIDOCAINE Advanced Rx LLC 9dff40d8-8d7e-4629-bea5-987f5e68477d 2024-06-11 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE Bryant Ranch Prepack 1d28d687-695e-4cd9-97e2-7d4fdab9772a 2024-06-05 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE PUREGEN LABS Maximum Strength Lidocaine LIDOCAINE Advanced Rx LLC f4f89582-49e6-424a-bea7-0694484a7c99 2024-04-11 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE Bryant Ranch Prepack b4db5684-988f-44c4-a81e-5c04b8b0f6e7 2024-04-05 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE Lidocaine LIDOCAINE Bryant Ranch Prepack 19c585f3-e635-44d4-8eb0-14529eb34dca 2024-04-03 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE Meijer Pain Relief Cream LIDOCAINE Meijer Distribution 07ecee44-387a-cdce-e063-6294a90ab9c9 2024-03-27 Warnings Name fallback generic name: LIDOCAINE Leader Burn Relief LIDOCAINE Cardinal Health f4e8e3b7-fd84-bdbc-e053-2a95a90aeab2 2024-02-06 Warnings Name fallback generic name: LIDOCAINE Aspercreme LIDOCAINE Lead Chemical Co. Ltd. 275e1343-deef-424a-a883-5e780083af91 2024-01-25 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE Bryant Ranch Prepack 65cf652c-87f2-43c6-a6f8-e4a83b42ce78 2024-01-24 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE Burn LIDOCAINE HART Health e95ebdac-9789-41c2-97da-2307e4538794 2024-01-18 Warnings Name fallback generic name: LIDOCAINE CVS Health Lidocaine Pain Relief LIDOCAINE Natural Essentials, Inc. 52e82e70-53b7-4ecb-be39-fe10c94cc444 2024-01-17 Warnings Name fallback generic name: LIDOCAINE CVS Health XL Lidocaine Pain Relief LIDOCAINE NATURAL ESSENTIALS, INC. ec16da91-8244-402b-b8d8-84896094ac2c 2024-01-17 Warnings Name fallback generic name: LIDOCAINE Salonpas Pain Relieving LIDOCAINE 4% FLEX LIDOCAINE Hisamitsu Pharmaceutical Co., Inc. 9507f727-c49f-4de4-9d64-b6d977d568ab 2024-01-17 Warnings Name fallback generic name: LIDOCAINE Lightning X Burn LIDOCAINE Nantong Health & Beyond Hygienic Products Inc. 0e69a971-0c6e-6ebe-e063-6394a90a0b33 2024-01-08 Warnings Name fallback generic name: LIDOCAINE Lidocaine Numbing Cream LIDOCAINE YYBA Corp de6dc194-c6ef-4cb5-be3f-e772ace9abaf 2024-01-03 Warnings Name fallback generic name: LIDOCAINE Bactine Max Bandage LIDOCAINE WellSpring Pharmaceutical Corporation 465dc46e-6435-4569-9516-f648d0fe0f09 2023-12-21 Warnings Name fallback generic name: LIDOCAINE Greencaine Blast LIDOCAINE ALMA Laboratories, Inc. 031e0065-4c8a-43d8-bc69-3efa3c6c0ae3 2023-12-12 Warnings Name fallback generic name: LIDOCAINE Prolayed Lidocaine Male Genital Desensitizer LIDOCAINE ViaDerma Distribution, Inc. 9c5ad0d0-ca7a-4321-9334-f06f3f6be18f 2023-12-02 Warnings Name fallback 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