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 12 of 16 · 307 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Xylocaine MPF LIDOCAINE HYDROCHLORIDE Fresenius Kabi USA, LLC d5e0d06f-ba1e-44d4-aa89-39d6c146dc23 2024-05-13 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Aspercreme with Lidocaine Pain Relieving Creme LIDOCAINE HYDROCHLORIDE Chattem, Inc. d5da67c3-c2ec-4e3e-abe9-cc862dcfc8bd 2024-05-01 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine HCl 4 Percent LIDOCAINE HYDROCHLORIDE ARI BRANDS, LLC 81aff5c5-91c0-4173-a432-d20115613580 2024-04-30 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Burn LIDOCAINE HYDROCHLORIDE JHK Inc 5a4ac4cc-015a-48e7-81f8-93a895049afd 2024-04-25 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Xylocaine MPF LIDOCAINE HYDROCHLORIDE Fresenius Kabi USA, LLC fe265eb5-eaeb-4f47-82dd-238c1d53fec4 2024-03-15 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE SunBurnt PLUS LIDOCAINE HYDROCHLORIDE Quest Products, LLC. 12128c75-015d-8a72-e063-6394a90ae00a 2024-02-23 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Kroger Analgesic Analgesic LIDOCAINE HYDROCHLORIDE THE KROGER CO e6c5ead3-87d0-48ed-a4dc-86cf89ebb285 2024-02-22 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE NuCare Pharmaceuticals,Inc. 0050d05a-b8e9-c544-e063-6294a90a0243 2024-02-08 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Safetec of America, Inc. 1c5eb3b3-79b3-472a-ae36-ec6a7dc72925 2024-02-07 Warnings Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Safetec of America, Inc. 8eb3e7e2-26e5-430e-89aa-40a0367c637e 2024-02-07 Warnings Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE HF Acquisition Co LLC, DBA HealthFirst c4bf5905-add7-1cb0-e053-2995a90a7334 2024-01-30 Warnings, Adverse reactions Name fallback brand name: LIDOCAINE HYDROCHLORIDE generic name: LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE HF Acquisition Co LLC, DBA HealthFirst c4c0df51-cc37-323d-e053-2995a90a154a 2024-01-30 Warnings, Adverse reactions Name fallback brand name: LIDOCAINE HYDROCHLORIDE generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Seton Pharmaceuticals 1c0abe84-5404-404e-b882-e910e4d43ffb 2024-01-30 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Burn LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. eca272cb-ac8f-982b-e053-2995a90aa8b2 2024-01-15 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Caring mill Lidocaine Aloe Gel Burn and Pain Relief LIDOCAINE HYDROCHLORIDE FSA Store Inc. 0ec20c87-1681-dd23-e063-6394a90a291c 2024-01-12 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS Spectra Medical Devices, LLC e8ba012a-08a9-4f67-9f88-3284377e80be 2024-01-12 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Golden State Medical Supply, Inc. 09c10cd0-b634-ab9d-e063-6294a90aa544 2024-01-09 Warnings, Adverse reactions Name fallback brand name: Lidocaine Hydrochloride generic name: LIDOCAINE HYDROCHLORIDE Theraworx Pain Relief Roll-On with Lidocaine for Diabetics LIDOCAINE HYDROCHLORIDE AVADIM HOLDINGS, INC. e07f5bf7-5a9a-468c-8c3f-2c6f0b17af29 2024-01-08 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE equate Maximum Strength Pain Relieving 4% Lidocaine with Lavender Essential Oil Topical analgesic LIDOCAINE HYDROCHLORIDE Wal-Mart Stores, Inc. bf954949-a7b7-44ba-8565-f1d5c0a6c0d1 2023-12-21 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Hikma Pharmaceuticals USA Inc. c5d27da0-e495-4bb6-a7e1-8eaa6595eb71 2023-12-14 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