Home Applications 040433 Application 040433
Type ANDA
Sponsor AKORN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE JELLY;TOPICAL 2% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A040433-001 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040433-001 AT
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT 2003-02-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040433-001 LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL AT RS 2003-02-12 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocaine LIDOCAINE HYDROCHLORIDE ARMAS PHARMACEUTICALS INC. 2f6e0f3d-ceaf-a853-e063-6394a90a8efb 2025-03-07 Warnings, Adverse reactions Exact identifier application applno (ANDA): 040433 application number: ANDA040433
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 19 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 17478-711 Lidocaine Lidocaine Hydrochloride Akorn, Inc. ANDA Current 17478-711 Lidocaine Lidocaine Hydrochloride Akorn ANDA Current 17478-711 Lidocaine Lidocaine Hydrochloride Akorn, Inc. ANDA Current 17478-711 Lidocaine Lidocaine Hydrochloride Akorn ANDA Current 17478-711 Lidocaine Lidocaine Hydrochloride Akorn, Inc. ANDA Current 17478-811 Lidocaine Lidocaine Hydrochloride Akorn, Inc. ANDA Current 17478-811 Lidocaine Lidocaine Hydrochloride Akorn, Inc. ANDA Current 17478-811 Lidocaine Lidocaine Hydrochloride Akorn, Inc. ANDA Current 17478-811 Lidocaine Lidocaine Hydrochloride Akorn ANDA Current 17478-840 Lidocaine Lidocaine Hydrochloride Akorn, Inc. ANDA Current 17478-840 Lidocaine Lidocaine Hydrochloride Akorn, Inc. ANDA Current 50090-0555 Lidocaine Lidocaine Hydrochloride A-S Medication Solutions ANDA Current 50090-0555 Lidocaine Lidocaine Hydrochloride A-S Medication Solutions ANDA Current 70529-254 Venipuncture Px1 Lidocaine Hydrochloride IT3 Medical LLC ANDA Current 70529-254 Venipuncture Px1 Lidocaine Hydrochloride IT3 Medical LLC ANDA Current 70529-254 Venipuncture Px1 Lidocaine Hydrochloride IT3 Medical LLC ANDA Current 70529-941 Sx1 Medicated Post-Operative System Lidocaine Hydrochloride IT3 Medical LLC ANDA Current 70529-941 Sx1 Medicated Post-Operative System Lidocaine Hydrochloride IT3 Medical LLC ANDA Current 70529-941 Sx1 Medicated Post-Operative System Lidocaine Hydrochloride IT3 Medical LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 22141 ORIG 2013-06-03