Home Applications 020554 Application 020554
Type NDA
Sponsor LEO PHARMA AS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DOVONEX CALCIPOTRIENE CREAM;TOPICAL 0.005% 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 N020554-001 DOVONEX CALCIPOTRIENE 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020554-001 AB
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 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020554-001 DOVONEX 0.005% CREAM / TOPICAL AB RLD, RS 1996-07-22 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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.
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 50222-260 Dovonex Calcipotriene LEO Pharma Inc. NDA Current 50222-260 Dovonex Calcipotriene LEO Pharma Inc. NDA Current 50222-260 Dovonex Calcipotriene LEO Pharma Inc. NDA Current 50222-260 Dovonex Calcipotriene LEO Pharma Inc. NDA Current 50222-260 Dovonex Calcipotriene LEO Pharma Inc. NDA Current 66993-877 Calcipotriene Calcipotriene Prasco Laboratories NDA AUTHORIZED GENERIC Current 66993-877 Calcipotriene Calcipotriene Prasco Laboratories NDA AUTHORIZED GENERIC Current 66993-877 Calcipotriene Calcipotriene Prasco Laboratories NDA AUTHORIZED GENERIC Current 66993-877 Calcipotriene Calcipotriene Prasco Laboratories NDA AUTHORIZED GENERIC Current 70859-048 NuDermRxPAK 60 Dimethicone, Calcipotriene NuCare Pharmaceuticals,Inc. NDA AUTHORIZED GENERIC Current 70859-049 NuDermRxPAK 120 Dimethicone, Calcipotriene NuCare Pharmaceuticals,Inc. NDA AUTHORIZED GENERIC Current 70859-055 NuDermRxPAK 60 Calcipotriene, Dimethicone NuCare Pharmaceuticals,Inc. NDA AUTHORIZED GENERIC Current 70859-055 NuDermRxPAK 60 Calcipotriene, Dimethicone NuCare Pharmaceuticals,Inc. NDA AUTHORIZED GENERIC Current 70859-056 NuDermRxPAK 120 Calcipotriene, Dimethicone NuCare Pharmaceuticals,Inc. NDA AUTHORIZED GENERIC Current 70859-056 NuDermRxPAK 120 Calcipotriene, Dimethicone NuCare Pharmaceuticals,Inc. NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 83682 SUPPL 2025-10-07 83672 SUPPL 2025-10-06 34818 SUPPL 2015-03-17 2715 SUPPL 2015-03-13 34817 SUPPL 2007-10-04 2714 SUPPL 2007-10-04 34816 SUPPL 2005-05-02 25161 SUPPL 2005-05-02