Home Applications 022221 Application 022221
Type NDA
Sponsor AKORN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AKTEN LIDOCAINE HYDROCHLORIDE GEL;OPHTHALMIC 3.5% Yes Yes
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 N022221-001 AKTEN LIDOCAINE HYDROCHLORIDE 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30
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 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022221-001 AKTEN 3.5% GEL / OPHTHALMIC RLD, RS 2008-10-07 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022221-001 8759401 2026-07-24 U-1523 Drug product 2014-06-30 cb3db0bc1861…
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 AKTEN LIDOCAINE HYDROCHLORIDE ANHYDROUS Thea Pharma Inc. 70ff9fb7-d323-4fe6-b1b1-6033e05f0749 2026-04-23 Warnings, Adverse reactions Exact identifier application applno (NDA): 022221 application number: NDA022221 ndc (product): 82584-792
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 17478-792 Akten Lidocaine Hydrochloride Akorn, Inc. NDA Current 17478-792 Akten Lidocaine Hydrochloride Akorn NDA Current 17478-792 Akten Lidocaine Hydrochloride Akorn, Inc. NDA Current 17478-792 Akten Lidocaine Hydrochloride Akorn NDA Current 82584-792 AKTEN LIDOCAINE HYDROCHLORIDE ANHYDROUS Thea Pharma Inc. NDA Current