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 2 of 16 · 307 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 462e9498-9eb9-456a-9022-659bcff93e3f 2026-07-17 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Painsil Pain Relief Roll-On LIDOCAINE HYDROCHLORIDE Painsil LLC dee39dff-5749-4ef2-a9ed-182f25e01f67 2026-07-14 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE Henry Schein, Inc. fa7dedcd-d78b-45f2-9dd7-f273043167d0 2026-07-14 Warnings, Adverse reactions Name fallback brand name: LIDOCAINE HYDROCHLORIDE generic name: LIDOCAINE HYDROCHLORIDE ZyloRelief LIDOCAINE HYDROCHLORIDE Highmark Pharma LLC 635f5b98-f74c-495f-a537-686fcba9ccad 2026-07-14 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE HF Acquisition Co LLC, DBA HealthFirst 2177b6fe-aa37-6f6b-e063-6294a90af09a 2026-07-10 Warnings, Adverse reactions Name fallback brand name: LIDOCAINE HYDROCHLORIDE generic name: LIDOCAINE HYDROCHLORIDE TopCare Health Pain Relief LIDOCAINE HYDROCHLORIDE Topco Associates LLC 485b0671-da09-19d7-e063-6294a90aca5d 2026-07-03 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE JJ Care BURN LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. d69ebc53-8552-449a-a973-f211328a3d3e 2026-07-03 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Desert Harvest Releveum with Lidocaine LIDOCAINE HYDROCHLORIDE Desert Harvest, Inc 9ad514ab-a6bd-4564-8ba3-0149032ebf36 2026-07-01 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE Henry Schein, Inc. cfbca641-aeee-4dc8-a340-30c53d3b023b 2026-07-01 Warnings, Adverse reactions Name fallback brand name: LIDOCAINE HYDROCHLORIDE generic name: LIDOCAINE HYDROCHLORIDE Lidozall Pro LIDOCAINE HYDROCHLORIDE V2 Pharma LLC ecc26ba7-4ff6-43e6-bfb9-91a9cbb509ff 2026-06-16 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Civica, Inc. 3c3b3888-fad3-440b-b627-6f79a2f4668f 2026-06-10 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE HealthWise Pain Relief Cream with Lidocaine LIDOCAINE HYDROCHLORIDE Veridian Healthcare ef176d33-10b9-ddb2-e053-2995a90a76e3 2026-06-10 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Aspercreme with Lidocaine No-Mess Applicator LIDOCAINE HYDROCHLORIDE Chattem, Inc. 8092cde7-28d0-4755-b5c0-5765934e572f 2026-05-29 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Sportpharm LLC 5b74b6f4-f26f-4243-8060-cd1777907984 2026-05-25 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Hospira, Inc. 89a4bd73-89f4-4fd7-2c9f-921e1da8f96b 2026-05-22 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine hydrochloride LIDOCAINE HYDROCHLORIDE Preferred Pharmaceuticals Inc. 55aa77b8-7601-4432-8631-bfec58daf247 2026-05-21 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Lidocaine hydrochloride generic name: LIDOCAINE HYDROCHLORIDE First Aid Only Lidocaine Hydrochloride Analgesic Burn Gel LIDOCAINE HYDROCHLORIDE Acme United Corporation 5258cef2-0e5c-4ccd-e063-6394a90a9e5c 2026-05-21 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Cardinal Health 107, LLC afd7c91b-3283-49e7-b79f-1c8d0c1a53bd 2026-05-20 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lightning X Burn Relief Gel LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. 515eb4cc-63af-c11d-e063-6294a90a13ca 2026-05-09 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE EVERLIT CARE PRODUCTS BURN RELIEF LIDOCAINE HYDROCHLORIDE EVERLIT GLOBAL INC. d7ec5720-4d1f-4943-ae36-c7d6acbae7d7 2026-05-04 Warnings 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