Home Applications 214269 Application 214269
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 4% 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 A214269-001 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214269-001 AP
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.
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 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214269-001 LIDOCAINE HYDROCHLORIDE 4% INJECTABLE / INJECTION AP 2022-05-05 a50c72e98297…
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 3 of 16 · 307 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EVERLIT CARE PRODUCTS BURN RELIEF LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. 5371dae4-ea63-46cc-ac26-5418f359c63e 2026-05-04 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE FIRSTAR BURN LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. 186343c5-2e71-49c4-8d64-5fb3131239fa 2026-05-04 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine LIDOCAINE HYDROCHLORIDE Sportpharm LLC cffda6fc-7e85-4c48-9623-2551d3552d7d 2026-04-24 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Camber Pharmaceuticals, Inc. 7f202319-effa-4dd8-b871-e720b75f4a83 2026-04-23 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Bryant Ranch Prepack 850bdb6a-85d9-441d-8666-7a61311386b6 2026-04-23 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine LIDOCAINE HYDROCHLORIDE Sportpharm LLC 7adb9ab0-ef91-4c51-baa3-a0b7e12df077 2026-04-21 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE Bryant Ranch Prepack 8f79b023-9bd1-4bd6-8fd0-f9efe88abec0 2026-04-20 Warnings, Adverse reactions Name fallback brand name: LIDOCAINE HYDROCHLORIDE generic name: LIDOCAINE HYDROCHLORIDE Lidocaine hydrochloride LIDOCAINE HYDROCHLORIDE Camber Pharmaceuticals, Inc. 9a1418e2-b208-4e5c-b5f8-21b3a691a578 2026-04-13 Warnings, Adverse reactions Name fallback brand name: Lidocaine hydrochloride generic name: LIDOCAINE HYDROCHLORIDE TATTOO NUMBX NUMBING PAIN RELIEVING LIDOCAINE HYDROCHLORIDE Scyberco Ltd ac8eac04-ed5b-4c8e-9f9b-54d160b74606 2026-04-02 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine hydrochloride LIDOCAINE HYDROCHLORIDE REMEDYREPACK INC. adc4dd69-45f3-48fe-bf85-f014b384c38e 2026-04-01 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Lidocaine hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Hikma Pharmaceuticals USA Inc. 1631e5ca-03d0-4d3b-91e3-2dc14f4eb0e1 2026-04-01 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Burn Mist LIDOCAINE HYDROCHLORIDE Water-Jel Technologies c53ab9dd-351a-400b-b873-4f396e0af54d 2026-03-31 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Satohap Lidocaine Hydrochloride 4 Percent Pain Relieving LIDOCAINE HYDROCHLORIDE Sato Pharmaceutical Co., Ltd. f7faddb2-5153-4fdd-a5ef-778182cef460 2026-03-31 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS Sportpharm LLC def640dd-bce2-4c18-9ee1-4a1cd5852e89 2026-03-20 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride Keeps Climax Delay LIDOCAINE HYDROCHLORIDE Cosco International, Inc. 3bfd3173-2dac-40a9-aec3-982b1d47d8fa 2026-03-12 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE CVS Foot Pain LIDOCAINE HYDROCHLORIDE CVS Pharmacy 4c3350c3-2e3e-093c-e063-6394a90a3475 2026-03-04 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Icy Hot Lidocaine No-Mess LIDOCAINE HYDROCHLORIDE Chattem, Inc. 347f9a18-8ab6-47d3-9610-5b4e9ca5d53a 2026-03-02 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Gold Bond Maximum Strength Foot Pain Relief LIDOCAINE HYDROCHLORIDE Gold Bond Co LLC 8e469076-2f5a-4de8-8d13-a38c072b9af8 2026-03-01 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE HealthWise Pain Relief Lidocaine LIDOCAINE HYDROCHLORIDE Veridian Healthcare 48ecbab9-13e0-d0fa-e063-6294a90a6ff2 2026-02-28 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Pain Relieving Gel LIDOCAINE HYDROCHLORIDE Chain Drug Marketing Association b55b7253-2fd2-45cc-b94c-e92395ab0d2b 2026-02-27 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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68055-649 NA Lidocaine Hydrochloride SINTETICA SA ANDA Current 68055-649 NA Lidocaine Hydrochloride SINTETICA SA ANDA Current 83090-007 NA Lidocaine Hydrochloride Sintetica US LLC ANDA Current