Home Applications 207154 Application 207154
Type NDA
Sponsor ALMIRALL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ACZONE DAPSONE GEL;TOPICAL 7.5% 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 N207154-001 ACZONE DAPSONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N207154-001 AB
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 N207154-001 11273132 2033-11-18 Drug product 2022-03-28
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 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N207154-001 ACZONE 7.5% GEL / TOPICAL RLD, RS 2016-02-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 3 · 90 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 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207154-001 9161926 2033-11-18 Drug product 2016-03-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207154-001 9517219 2033-11-18 U-1033 2016-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207154-001 9161926 2033-11-18 Drug product 2016-03-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207154-001 9517219 2033-11-18 U-1033 2016-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207154-001 9161926 2033-11-18 Drug product 2016-03-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207154-001 9517219 2033-11-18 U-1033 2016-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N207154-001 9161926 2033-11-18 Drug product 2016-03-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N207154-001 9517219 2033-11-18 U-1033 2016-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207154-001 9161926 2033-11-18 Drug product 2016-03-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207154-001 9517219 2033-11-18 U-1033 2016-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N207154-001 9161926 2033-11-18 Drug product 2016-03-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N207154-001 9517219 2033-11-18 U-1033 2016-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207154-001 9161926 2033-11-18 Drug product 2016-03-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N207154-001 9517219 2033-11-18 U-1033 2016-12-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207154-001 9161926 2033-11-18 Drug product 2016-03-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N207154-001 9517219 2033-11-18 U-1033 2016-12-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207154-001 9161926 2033-11-18 Drug product 2016-03-01 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N207154-001 9517219 2033-11-18 U-1033 2016-12-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207154-001 9161926 2033-11-18 Drug product 2016-03-01 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N207154-001 9517219 2033-11-18 U-1033 2016-12-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N207154-001 9161926 2033-11-18 Drug product 2016-03-01 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N207154-001 9517219 2033-11-18 U-1033 2016-12-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N207154-001 9161926 2033-11-18 Drug product 2016-03-01 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N207154-001 9517219 2033-11-18 U-1033 2016-12-16 5aa47cf7b7d7…
Observed Orange Book exclusivity history# 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0023-5206 ACZONE dapsone Allergan, Inc. NDA Current 0023-5206 ACZONE dapsone Allergan, Inc. NDA Current 0023-5206 ACZONE dapsone Allergan, Inc. NDA Current 16110-526 Aczone dapsone Almirall, LLC NDA Current 16110-526 Aczone dapsone Almirall, LLC NDA Current 16110-526 Aczone dapsone Almirall, LLC NDA Current 51672-5307 Dapsone Dapsone Taro Pharmaceuticals U.S.A., Inc. NDA AUTHORIZED GENERIC Current 51672-5307 Dapsone Dapsone Taro Pharmaceuticals U.S.A., Inc. NDA Current