Home Applications 204623 Application 204623
Type NDA
Sponsor HORIZON Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PENNSAID DICLOFENAC SODIUM SOLUTION;TOPICAL 2% Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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date N204623-001 PENNSAID DICLOFENAC SODIUM 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / TOPICAL RLD 2014-01-16
Orange Book patents# Current patent rows page 1 of 1 · 20 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 · 43 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 N204623-001 PENNSAID 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / TOPICAL RLD 2014-01-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N204623-001 PENNSAID 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / TOPICAL RLD 2014-01-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204623-001 PENNSAID 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / TOPICAL RLD 2014-01-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204623-001 PENNSAID 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / TOPICAL RLD 2014-01-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204623-001 PENNSAID 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / TOPICAL RLD 2014-01-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204623-001 PENNSAID 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / TOPICAL RLD 2014-01-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204623-001 PENNSAID 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / TOPICAL RLD 2014-01-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204623-001 PENNSAID 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / TOPICAL RLD 2014-01-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204623-001 PENNSAID 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / TOPICAL RLD 2014-01-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204623-001 PENNSAID 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / TOPICAL RLD 2014-01-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204623-001 PENNSAID 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / TOPICAL RLD 2014-01-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204623-001 PENNSAID 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / TOPICAL RLD 2014-01-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204623-001 PENNSAID 2% SOLUTION / TOPICAL RLD 2014-01-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204623-001 PENNSAID 2% SOLUTION / TOPICAL RLD 2014-01-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204623-001 PENNSAID 2% SOLUTION / TOPICAL RLD 2014-01-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204623-001 PENNSAID 2% SOLUTION / TOPICAL RLD 2014-01-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204623-001 PENNSAID 2% SOLUTION / TOPICAL AB RLD, RS 2014-01-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204623-001 PENNSAID 2% SOLUTION / TOPICAL RLD, RS 2014-01-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204623-001 PENNSAID 2% SOLUTION / TOPICAL RLD, RS 2014-01-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204623-001 PENNSAID 2% SOLUTION / TOPICAL RLD, RS 2014-01-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204623-001 PENNSAID 2% SOLUTION / TOPICAL RLD, RS 2014-01-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N204623-001 PENNSAID 2% SOLUTION / TOPICAL RLD, RS 2014-01-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N204623-001 PENNSAID 2% SOLUTION / TOPICAL RLD, RS 2014-01-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N204623-001 PENNSAID 2% SOLUTION / TOPICAL RLD, RS 2014-01-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N204623-001 PENNSAID 2% SOLUTION / TOPICAL RLD, RS 2014-01-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N204623-001 PENNSAID 2% SOLUTION / TOPICAL RLD, RS 2014-01-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N204623-001 PENNSAID 2% SOLUTION / TOPICAL RLD, RS 2014-01-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N204623-001 PENNSAID 2% SOLUTION / TOPICAL RLD, RS 2014-01-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N204623-001 PENNSAID 2% SOLUTION / TOPICAL RLD, RS 2014-01-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N204623-001 PENNSAID 2% SOLUTION / TOPICAL AB RLD, RS 2014-01-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N204623-001 PENNSAID 2% SOLUTION / TOPICAL AB RLD, RS 2014-01-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N204623-001 PENNSAID 2% SOLUTION / TOPICAL AB RLD, RS 2014-01-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N204623-001 PENNSAID 2% SOLUTION / TOPICAL AB RLD, RS 2014-01-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N204623-001 PENNSAID 2% SOLUTION / TOPICAL AB RLD, RS 2014-01-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N204623-001 PENNSAID 2% SOLUTION / TOPICAL AB RLD, RS 2014-01-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N204623-001 PENNSAID 2% SOLUTION / TOPICAL AB RLD, RS 2014-01-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N204623-001 PENNSAID 2% SOLUTION / TOPICAL AB RLD, RS 2014-01-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N204623-001 PENNSAID 2% SOLUTION / TOPICAL AB RLD, RS 2014-01-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N204623-001 PENNSAID 2% SOLUTION / TOPICAL AB RLD, RS 2014-01-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N204623-001 PENNSAID 2% SOLUTION / TOPICAL AB RLD, RS 2014-01-16 f41ea6bd6efb…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 22 · 860 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N204623-001 8563613 2027-10-17 U-1488 Drug product 2014-02-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204623-001 8871809 2027-10-17 U-1614 2014-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204623-001 9066913 2027-10-17 U-1488 Drug product 2015-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204623-001 9101591 2027-10-17 U-1488 Drug product 2015-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204623-001 9132110 2027-10-17 U-1488 2015-09-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204623-001 9168304 2027-10-17 Drug product 2015-10-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204623-001 9168305 2027-10-17 U-1488 2015-10-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204623-001 9220784 2027-10-17 U-1488 2016-01-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204623-001 9339551 2027-10-17 U-1488 2016-06-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204623-001 9339552 2027-10-17 U-1488 Drug product 2016-06-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204623-001 9539335 2027-10-17 U-1614 2016-02-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204623-001 8252838 2028-04-21 U-1489 Drug product 2014-02-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204623-001 8217078 2029-07-10 U-1477 2014-02-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204623-001 8618164 2029-07-10 U-1477 2014-02-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204623-001 8741956 2029-07-10 U-1435 2014-06-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204623-001 9370501 2029-07-10 U-1614 2016-07-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204623-001 9375412 2029-07-10 U-1614 2016-07-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204623-001 9415029 2029-07-10 U-1614 2016-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204623-001 8546450 2030-08-09 U-1435 2014-02-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204623-001 8546450 2030-08-09 U-1436 2014-02-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N204623-001 8563613 2027-10-17 U-1488 Drug product 2014-02-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204623-001 8871809 2027-10-17 U-1614 2014-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204623-001 9066913 2027-10-17 U-1488 Drug product 2015-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204623-001 9101591 2027-10-17 U-1488 Drug product 2015-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204623-001 9132110 2027-10-17 U-1488 2015-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204623-001 9168304 2027-10-17 Drug product 2015-10-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204623-001 9168305 2027-10-17 U-1488 2015-10-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204623-001 9220784 2027-10-17 U-1488 2016-01-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204623-001 9339551 2027-10-17 U-1488 2016-06-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204623-001 9339552 2027-10-17 U-1488 Drug product 2016-06-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204623-001 9539335 2027-10-17 U-1614 2016-02-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204623-001 8252838 2028-04-21 U-1489 Drug product 2014-02-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204623-001 8217078 2029-07-10 U-1477 2014-02-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204623-001 8618164 2029-07-10 U-1477 2014-02-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204623-001 8741956 2029-07-10 U-1435 2014-06-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204623-001 9370501 2029-07-10 U-1614 2016-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204623-001 9375412 2029-07-10 U-1614 2016-07-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204623-001 9415029 2029-07-10 U-1614 2016-09-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204623-001 8546450 2030-08-09 U-1435 2014-02-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204623-001 8546450 2030-08-09 U-1436 2014-02-25 caaa826d4ba7…
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 14 · 273 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Diclofenac Sodium DICLOFENAC SODIUM A-S Medication Solutions 50efc183-dd3e-4eb7-ba5c-c42fd76e0b65 2023-12-25 Boxed warning, Warnings, Adverse reactions Name fallback generic name: DICLOFENAC SODIUM DICLOFENAC SODIUM DICLOFENAC SODIUM Proficient Rx LP f19bf286-f4dd-4491-90c3-9f8713071903 2023-12-01 Boxed warning, Warnings, Adverse reactions Name fallback generic name: DICLOFENAC SODIUM Diclofenac Sodium DICLOFENAC SODIUM CVS Pharmacy e9ccaf95-582b-4d4d-938f-7577eaa8dffb 2023-11-27 Warnings Name fallback generic name: DICLOFENAC SODIUM Diclofenac Sodium Delayed Release DICLOFENAC SODIUM Bryant Ranch Prepack e6a1ff58-a541-46f8-9663-eed53b7cf392 2023-11-16 Boxed warning, Warnings, Adverse reactions Name fallback generic name: DICLOFENAC SODIUM Diclofenac Sodium DICLOFENAC SODIUM A-S Medication Solutions 51756947-e802-4b4d-883e-fd6f22e9a725 2023-10-24 Boxed warning, Warnings, Adverse reactions Name fallback generic name: DICLOFENAC SODIUM Diclofenac Sodium Delayed Release DICLOFENAC SODIUM A-S Medication Solutions 9df87100-acf5-4b46-93b4-067b470136bd 2023-10-23 Boxed warning, Warnings, Adverse reactions Name fallback generic name: DICLOFENAC SODIUM Arthritis Pain Reliever DICLOFENAC SODIUM CVS PHARMACY, INC 4808015d-cfee-4f4d-a84b-82099f0b4868 2023-10-04 Warnings Name fallback generic name: DICLOFENAC SODIUM Diclofenac Sodium DICLOFENAC SODIUM A-S Medication Solutions 0379c918-1717-40ab-81cc-268116950fd5 2023-10-03 Boxed warning, Warnings, Adverse reactions Name fallback generic name: DICLOFENAC SODIUM Diclofenac sodium DICLOFENAC SODIUM Asclemed USA, Inc. 6a9c3cea-7b46-427d-99af-90c1f290b190 2023-09-02 Boxed warning, Warnings, Adverse reactions Name fallback generic name: DICLOFENAC SODIUM equaline arthritis pain relieving DICLOFENAC SODIUM United Natural Foods, Inc. dba UNFI 748b6134-0c1d-4e9c-a93a-fcc6e4d0b6d0 2023-08-23 Warnings Name fallback generic name: DICLOFENAC SODIUM Diclofenac Sodium DICLOFENAC SODIUM Aurohealth LLC 2a599579-b2b0-4423-8e30-fe04bf815870 2023-08-11 Warnings Name fallback generic name: DICLOFENAC SODIUM Arthritis Pain Reliever DICLOFENAC SODIUM AmerisourceBergen (Good Neighbor Pharmacy) 46122 30e1f589-b322-48b7-9a97-502afe2a1baa 2023-08-09 Warnings Name fallback generic name: DICLOFENAC SODIUM equate arthritis pain DICLOFENAC SODIUM Wal-Mart Stores Inc 5e80f6b6-b3f4-4b76-82da-1fc98cb9ad1b 2023-07-27 Warnings Name fallback generic name: DICLOFENAC SODIUM berkley and jensen arthritis pain DICLOFENAC SODIUM BJWC 441cf367-b293-47e8-a8fb-32e3314be7de 2023-07-26 Warnings Name fallback generic name: DICLOFENAC SODIUM diclofenac sodium DICLOFENAC SODIUM Bryant Ranch Prepack 16853c78-493a-4b8b-87b9-97dc927e1c8e 2023-07-14 Boxed warning, Warnings, Adverse reactions Name fallback generic name: DICLOFENAC SODIUM CareOne arthritis pain relief DICLOFENAC SODIUM American Sales Company 69615972-b593-44fb-ae49-9441d872d84a 2023-06-08 Warnings Name fallback generic name: DICLOFENAC SODIUM DG health arthritis pain DICLOFENAC SODIUM Dolgencorp Inc e7f93d8f-df2b-4005-b58d-c6f10ae0e0f3 2023-05-24 Warnings Name fallback generic name: DICLOFENAC SODIUM arthritis pain reliever DICLOFENAC SODIUM Publix Super Markets Inc 445de976-9a28-4e97-929f-c77aeb21c1fa 2023-05-15 Warnings Name fallback generic name: DICLOFENAC SODIUM arthritis pain relieving DICLOFENAC SODIUM Meijer Distribution Inc d46a4841-2f86-4e0e-ac79-9b1444ed4f79 2023-05-15 Warnings Name fallback generic name: DICLOFENAC SODIUM topcare athritis pain reliever DICLOFENAC SODIUM Topco Associates LLC d3e9416d-e13b-4cc7-a663-6df3534b8dbe 2023-05-10 Warnings Name fallback generic name: DICLOFENAC SODIUM
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 · 15 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0574-0167 DICLOFENAC SODIUM diclofenac sodium Padagis US LLC NDA AUTHORIZED GENERIC Current 63629-9603 DICLOFENAC SODIUM diclofenac sodium Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current 70518-2492 Pennsaid diclofenac sodium REMEDYREPACK INC. NDA Current 70518-2492 Pennsaid diclofenac sodium REMEDYREPACK INC. NDA Current 70518-2492 Pennsaid diclofenac sodium REMEDYREPACK INC. NDA Current 70518-2492 Pennsaid diclofenac sodium REMEDYREPACK INC. NDA Current 70518-2492 Pennsaid diclofenac sodium REMEDYREPACK INC. NDA Current 70748-335 Diclofenac Sodium Diclofenac Sodium Lupin Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current 75987-040 Pennsaid diclofenac sodium Horizon Therapeutics USA, Inc. NDA Current 75987-040 Pennsaid diclofenac sodium Horizon Therapeutics USA, Inc. NDA Current 75987-040 Pennsaid diclofenac sodium Horizon Therapeutics USA, Inc. NDA Current 75987-040 Pennsaid diclofenac sodium Horizon Therapeutics USA, Inc. NDA Current 75987-040 Pennsaid diclofenac sodium Horizon Therapeutics USA, Inc. NDA Current 75987-040 Pennsaid diclofenac sodium Horizon Therapeutics USA, Inc. NDA Current 75987-040 Pennsaid diclofenac sodium Horizon Pharma Inc. NDA Current