Home Applications 214267 Application 214267
Type ANDA
Sponsor SINTETICA SA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% No No 002 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 2% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214267-001 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-09-19 A214267-002 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2022-09-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 56 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 A214267-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-09-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214267-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2022-09-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214267-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-09-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214267-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2022-09-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214267-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-09-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214267-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2022-09-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214267-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-09-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214267-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2022-09-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214267-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-09-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214267-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2022-09-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214267-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-09-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214267-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2022-09-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214267-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-09-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214267-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2022-09-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214267-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-09-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214267-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2022-09-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214267-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-09-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214267-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2022-09-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214267-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-09-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214267-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2022-09-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214267-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-09-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214267-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2022-09-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214267-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-09-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214267-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2022-09-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214267-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-09-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214267-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2022-09-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214267-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-09-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214267-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2022-09-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214267-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-09-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214267-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2022-09-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214267-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-09-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A214267-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2022-09-19 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214267-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-09-19 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214267-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2022-09-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214267-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-09-19 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A214267-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2022-09-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214267-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-09-19 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A214267-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2022-09-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214267-001 LIDOCAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION AP 2022-09-19 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214267-002 LIDOCAINE HYDROCHLORIDE 2% INJECTABLE / INJECTION AP 2022-09-19 a72a2bbeb626…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 56 observed states.
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 11 of 16 · 307 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Theraworx PM Nighttime Maximum Strength Pain Relief LIDOCAINE HYDROCHLORIDE AVADIM HOLDINGS, INC. bc8cb476-9a47-47b3-ad78-a6ecec9ee66f 2024-09-19 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Eugia US LLC ef782e5e-e2d7-465a-99c6-b12611f3158c 2024-09-12 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Meijer Analgesic Lidocaine Topical Analgesic LIDOCAINE HYDROCHLORIDE Meijer Distribution, Inc f5d39be6-3b91-4ba1-9015-fd3ffbbdf4aa 2024-09-12 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Accucaine LIDOCAINE HYDROCHLORIDE Advanced Rx Pharmacy of Tennessee, LLC 01679d29-a592-8cbb-e063-6394a90ad82a 2024-09-11 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Lifestar Pharma LLC 9cb98fb0-5204-4973-8be7-f44ddbfde2ab 2024-09-03 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Wildman Business Group 1fd1a4b3-b6fd-0d4c-e063-6394a90a3680 2024-09-01 Warnings Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE International Medication Systems, Limited 0cbc37d3-c2d6-4747-9834-7c23b38fcc20 2024-08-30 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE NuCare Pharmaceuticals,Inc. 5a41d694-4628-4911-e053-2991aa0a91e5 2024-08-14 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Lifestar Pharma LLC 8149138a-4106-4ae6-b7ad-f2559c7fa7e2 2024-08-13 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidotral 5 Percent Roll On Gel LIDOCAINE HYDROCHLORIDE Puretek Corporation 1c4c9ce5-f12d-9c47-e063-6294a90a0b3c 2024-08-02 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Fruit of the Earth Aloe Vera Cool Blue LIDOCAINE HYDROCHLORIDE Fruit of the Earth, Inc. 1d65bc34-2bc2-4f52-a9b3-1cb08324eb79 2024-07-19 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE CVS Health Sunburn Relief Cooling LIDOCAINE HYDROCHLORIDE CVS PHARMACY 1d6402ea-4201-27f9-e063-6294a90a43f5 2024-07-16 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE NorthStar RxLLC f065e6d2-b47e-433d-a1fb-f0449cd725f1 2024-07-05 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE HF Acquisition Co LLC, DBA HealthFirst 1b584ef0-3663-0d2a-e063-6394a90a1757 2024-06-20 Warnings, Adverse reactions Name fallback brand name: LIDOCAINE HYDROCHLORIDE generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Asclemed USA, Inc. 45416533-17a1-4757-b24e-b33d1ee57471 2024-06-20 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidotral Five Percent LIDOCAINE HYDROCHLORIDE PureTek Corporation 1a156ffe-1ec9-d2f9-e063-6394a90a3381 2024-06-04 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE THE SOLUTION NUMBING LIDOCAINE HYDROCHLORIDE SCALP TECH INC 184be4cc-b0b9-7882-e063-6394a90a8e7e 2024-05-25 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE TheraCare 4% Lidocaine Cream LIDOCAINE HYDROCHLORIDE Veridian Healthcare c808aa05-9d49-cc9f-e053-2a95a90a50f3 2024-05-21 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE SAFLY Burn LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. 3aca2568-d10f-4b14-861b-6c741c106829 2024-05-17 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidotral Two Percent LIDOCAINE HYDROCHLORIDE PureTek Corporation 185d3e09-4005-b032-e063-6294a90a5efe 2024-05-14 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE
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 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68055-641 NA LIDOCAINE HYDROCHLORIDE SINTETICA SA ANDA Current 68055-642 NA LIDOCAINE HYDROCHLORIDE SINTETICA SA ANDA Current 68055-643 NA LIDOCAINE HYDROCHLORIDE SINTETICA SA ANDA Current 68055-645 NA LIDOCAINE HYDROCHLORIDE SINTETICA SA ANDA Current 68055-646 NA LIDOCAINE HYDROCHLORIDE SINTETICA SA ANDA Current 68055-647 NA LIDOCAINE HYDROCHLORIDE SINTETICA SA ANDA Current 83090-001 NA LIDOCAINE HYDROCHLORIDE Sintetica US LLC ANDA Current 83090-002 NA LIDOCAINE HYDROCHLORIDE Sintetica US LLC ANDA Current 83090-003 NA LIDOCAINE HYDROCHLORIDE Sintetica US LLC ANDA Current 83090-004 NA LIDOCAINE HYDROCHLORIDE Sintetica US LLC ANDA Current 83090-005 NA LIDOCAINE HYDROCHLORIDE Sintetica US LLC ANDA Current 83090-006 NA LIDOCAINE HYDROCHLORIDE Sintetica US LLC ANDA Current