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 8 of 16 · 307 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MediFirst Burn LIDOCAINE HYDROCHLORIDE Unifirst First Aid Corporation 9fa5b348-29c2-4cd0-a945-0486bd27f5e0 2025-09-08 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Unifirst First Aid Corporation 4c2e2b91-d2f6-4e41-9a4c-ecabca9830e8 2025-09-08 Warnings Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE HealthWise 4% Lidocaine Cream 2.7 oz LIDOCAINE HYDROCHLORIDE Veridian Healthcare f39eb3d0-e153-4f50-85b1-ad5c677d176c 2025-08-28 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Cintas First Aid & Safety 96f17095-31f3-4b8a-ab22-0caaefaa7476 2025-08-15 Warnings Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Aruba Aloe Alcoholada LIDOCAINE HYDROCHLORIDE Aruba Aloe Balm NV f56c62b0-75db-4499-858e-54e10b0e140a 2025-08-07 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Lannett Company, Inc. c3353e08-2a8c-4ace-ba89-114f7131b8de 2025-08-07 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE Aurobindo Pharma Limited ab461805-413a-4fb3-88a1-224e1c423084 2025-07-30 Boxed warning, Warnings, Adverse reactions Name fallback brand name: LIDOCAINE HYDROCHLORIDE generic name: LIDOCAINE HYDROCHLORIDE QUALITY CHOICE Maximum Strength Lidocaine Pain Relief Roll On LIDOCAINE HYDROCHLORIDE CHAIN DRUG MARKETING ASSOCIATION 7b3ff4c1-0b60-4f7a-8aa4-c84b7c7137c4 2025-07-11 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Sun Pharmaceutical Industries, Inc. 845b96c1-36a3-431f-8316-112ae881d934 2025-07-07 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE Henry Schein, Inc. 767374af-89d1-4c19-bd8e-480699b45cf7 2025-06-11 Warnings, Adverse reactions Name fallback brand name: LIDOCAINE HYDROCHLORIDE generic name: LIDOCAINE HYDROCHLORIDE Burn LIDOCAINE HYDROCHLORIDE J&A Digital Inc. d4b09055-b93e-466f-9e24-cae098af6e24 2025-06-02 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Xylocaine LIDOCAINE HYDROCHLORIDE Asclemed USA, Inc. 25370b0f-0ac6-4a03-abe6-d73d65192180 2025-05-31 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine hydrochloride LIDOCAINE HYDROCHLORIDE ATLANTIC BIOLOGICALS CORP. 75d17334-6876-42d0-8a02-82669d139e4f 2025-05-12 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Lidocaine hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Huons Co., Ltd. 8ec2d256-fc4f-44f6-bee2-eef2bf3bf580 2025-05-09 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine LIDOCAINE HYDROCHLORIDE Hikma Pharmaceuticals USA Inc. 5523fdfe-69fd-49a5-b51f-73e2223d49a9 2025-05-01 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Xylocaine LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE Fresenius Kabi USA, LLC 4dd52202-8eef-4136-92dd-ada573b7cf74 2025-04-22 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE Xttrium Laboratories, Inc. 31a5a48e-27d7-90f3-e063-6294a90a2d9e 2025-03-31 Warnings, Adverse reactions Name fallback brand name: LIDOCAINE HYDROCHLORIDE generic name: LIDOCAINE HYDROCHLORIDE Lidocaine LIDOCAINE HYDROCHLORIDE Fresenius Kabi USA, LLC cddb2b22-fce3-8967-6e54-dca3df5ac4b3 2025-03-26 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Preferred Pharmaceuticals Inc. abf60c5c-66df-4894-aa8f-bf770a6e9d00 2025-03-24 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine hydrochloride LIDOCAINE HYDROCHLORIDE NuCare Pharmaceuticals,Inc. 037764d3-da0e-5ebb-e063-6294a90ab6e0 2025-03-19 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Lidocaine hydrochloride 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