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 7 of 16 · 307 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Xylocaine LIDOCAINE HYDROCHLORIDE Henry Schein, Inc. ffc87dfb-0e26-4b42-80fd-3fb7690119e3 2025-11-07 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine hydrochloride LIDOCAINE HYDROCHLORIDE A-S Medication Solutions e67dee40-b243-4d6b-bc6b-e52c6cb798b8 2025-11-01 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Lidocaine hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Henry Schein, Inc. f73d4546-c9ac-4155-8492-552d6ce70c84 2025-10-31 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Henry Schein, Inc. f0617ab8-555f-4cbe-9795-c922f5ef176e 2025-10-31 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Henry Schein, Inc. ddaee8bc-f55c-48b1-9b0e-ad1e2dd15a2c 2025-10-31 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Marlex Pharmaceuticals, Inc. e1badbba-59af-e451-e053-2a95a90a49f8 2025-10-30 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Medical Purchasing Solutions, LLC. 42531a38-7cff-de16-e063-6394a90a18d8 2025-10-29 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine LIDOCAINE HYDROCHLORIDE A-S Medication Solutions e6c83ad7-2821-432b-8610-0f54cfe610cb 2025-10-21 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Ear Pain MD LIDOCAINE HYDROCHLORIDE Eosera Inc 78c4418f-7f0f-447f-a94f-d4c89a081af1 2025-10-17 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Trilocaine LIDOCAINE HYDROCHLORIDE Trifluent Pharma LLC c58257bf-f06b-48d1-92df-a680dbd5eea0 2025-10-15 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Trilogel LIDOCAINE HYDROCHLORIDE Trifluent Pharma LLC 22af7d63-6a56-4a38-a95b-0f88410b23cb 2025-10-14 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE The J. Molner Company LLC 17880468-873f-6465-e063-6294a90a9c73 2025-10-06 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE equate Burn Relief LIDOCAINE HYDROCHLORIDE Walmart Inc a90cbd92-80a5-4463-8152-b83165121a6f 2025-10-02 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine hydrochloride LIDOCAINE HYDROCHLORIDE Xttrium Laboratories, Inc. 40339593-1142-53ef-e063-6394a90afd4f 2025-10-02 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Lidocaine hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine hydrochloride LIDOCAINE HYDROCHLORIDE Atlantic Biologicals Corp. 401ecb6c-392b-1d74-e063-6294a90a4005 2025-10-01 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Lidocaine hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS Henry Schein, Inc. bb53bb10-bb36-4c9b-b632-71455615f9f3 2025-09-29 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE Henry Schein, Inc. ee21518e-b3ed-405a-ac3b-bfe753893dba 2025-09-29 Warnings, Adverse reactions Name fallback brand name: LIDOCAINE HYDROCHLORIDE generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS Henry Schein, Inc. a5d4b206-cc53-470f-9bca-abfc6ea5cc99 2025-09-29 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride Lidocaine Hydrochloride LIDOCAINE Henry Schein, Inc. 0c0790ec-effd-4d8a-9874-8ca0b31e54d0 2025-09-29 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride Medi-First Burn LIDOCAINE HYDROCHLORIDE Unifirst First Aid Corporation 44bb5f25-1114-4bb1-8bcf-40402594abc4 2025-09-09 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