Home Applications 204141 Application 204141
Type NDA
Sponsor TARO PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TOPICORT DESOXIMETASONE SPRAY;TOPICAL 0.25% Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N204141-001 TOPICORT DESOXIMETASONE 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N204141-001 AT
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26
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 · 42 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 2026-08-18 06:07:40 2026-07 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book patent history# Patent history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 bb7c543d1eb4…
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 · 2 matching rows.
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 51672-1396 Desoximetasone Desoximetasone Taro Pharmaceuticals U.S.A., Inc. NDA AUTHORIZED GENERIC Current 51672-1396 Desoximetasone Desoximetasone Taro Pharmaceuticals U.S.A., Inc. NDA AUTHORIZED GENERIC Current 51672-5281 Topicort Desoximetasone Taro Pharmaceuticals U.S.A., Inc. NDA Current 51672-5281 Topicort Desoximetasone Taro Pharmaceuticals U.S.A., Inc. NDA Current 51672-5281 Topicort Desoximetasone Taro Pharmaceuticals U.S.A., Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 68976 SUPPL 2021-10-13 68952 SUPPL 2021-10-12 32516 SUPPL 2015-12-17 19530 SUPPL 2015-12-17 44896 ORIG 2013-11-05 22944 ORIG 2013-11-05 40357 ORIG 2013-04-16 32515 ORIG 2013-04-16