Home Applications 207589 Application 207589
Type NDA
Sponsor LEO PHARMA AS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ENSTILAR BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE AEROSOL, FOAM;TOPICAL 0.064%;0.005% 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 N207589-001 ENSTILAR BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16
Orange Book patents# Current patent rows page 1 of 1 · 11 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N207589-001 10130640 2031-06-10 Drug product 2018-12-06 N207589-001 10617698 2031-06-10 Drug product 2020-04-15 N207589-001 10660908 2031-06-10 U-2627 Drug product 2020-06-17 N207589-001 10682364 2031-06-10 Drug product 2020-07-16 N207589-001 10688108 2031-06-10 U-2627 2020-07-23 N207589-001 10716799 2031-06-10 Drug product 2020-08-19 N207589-001 9119781 2031-06-10 U-1761 Drug product 2015-11-12 N207589-001 9119781 2031-06-10 U-2627 Drug product 2015-11-12 N207589-001 9566286 2031-06-10 Drug product 2019-11-15 N207589-001 10130640*PED 2031-12-10 Pediatric extension N207589-001 9119781*PED 2031-12-10 Pediatric extension
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 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 11 · 434 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 N207589-001 10130640 2031-06-10 Drug product 2018-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207589-001 10617698 2031-06-10 Drug product 2020-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207589-001 10660908 2031-06-10 U-2627 Drug product 2020-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207589-001 10682364 2031-06-10 Drug product 2020-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207589-001 10688108 2031-06-10 U-2627 2020-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207589-001 10716799 2031-06-10 Drug product 2020-08-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207589-001 9119781 2031-06-10 U-1761 Drug product 2015-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207589-001 9119781 2031-06-10 U-2627 Drug product 2015-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207589-001 9566286 2031-06-10 Drug product 2019-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207589-001 10130640*PED 2031-12-10 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207589-001 9119781*PED 2031-12-10 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207589-001 10130640 2031-06-10 Drug product 2018-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207589-001 10617698 2031-06-10 Drug product 2020-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207589-001 10660908 2031-06-10 U-2627 Drug product 2020-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207589-001 10682364 2031-06-10 Drug product 2020-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207589-001 10688108 2031-06-10 U-2627 2020-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207589-001 10716799 2031-06-10 Drug product 2020-08-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207589-001 9119781 2031-06-10 U-1761 Drug product 2015-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207589-001 9119781 2031-06-10 U-2627 Drug product 2015-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207589-001 9566286 2031-06-10 Drug product 2019-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207589-001 10130640*PED 2031-12-10 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207589-001 9119781*PED 2031-12-10 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207589-001 10130640 2031-06-10 Drug product 2018-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207589-001 10617698 2031-06-10 Drug product 2020-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207589-001 10660908 2031-06-10 U-2627 Drug product 2020-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207589-001 10682364 2031-06-10 Drug product 2020-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207589-001 10688108 2031-06-10 U-2627 2020-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207589-001 10716799 2031-06-10 Drug product 2020-08-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207589-001 9119781 2031-06-10 U-1761 Drug product 2015-11-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207589-001 9119781 2031-06-10 U-2627 Drug product 2015-11-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207589-001 9566286 2031-06-10 Drug product 2019-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207589-001 10130640*PED 2031-12-10 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207589-001 9119781*PED 2031-12-10 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207589-001 10130640 2031-06-10 Drug product 2018-12-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207589-001 10617698 2031-06-10 Drug product 2020-04-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207589-001 10660908 2031-06-10 U-2627 Drug product 2020-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207589-001 10682364 2031-06-10 Drug product 2020-07-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207589-001 10688108 2031-06-10 U-2627 2020-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207589-001 10716799 2031-06-10 Drug product 2020-08-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207589-001 9119781 2031-06-10 U-1761 Drug product 2015-11-12 fd3edfee7708…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ENSTILAR CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE LEO Pharma Inc. d1193df2-d53f-4342-bd9d-d9cba7c89709 2021-10-18 Warnings, Adverse reactions Exact identifier application applno (NDA): 207589 application number: NDA207589 ndc (product): 50222-302
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 50222-302 ENSTILAR calcipotriene and betamethasone dipropionate LEO Pharma Inc. NDA Current 50222-302 ENSTILAR calcipotriene and betamethasone dipropionate LEO Pharma Inc. NDA Current 50222-302 ENSTILAR calcipotriene and betamethasone dipropionate LEO Pharma Inc. NDA Current 50222-302 ENSTILAR calcipotriene and betamethasone dipropionate LEO Pharma Inc. NDA Current 50222-302 ENSTILAR calcipotriene and betamethasone dipropionate LEO Pharma Inc. NDA Current 50222-302 ENSTILAR calcipotriene and betamethasone dipropionate LEO Pharma Inc. NDA Current 50222-302 ENSTILAR calcipotriene and betamethasone dipropionate LEO Pharma Inc. NDA Current 50222-302 ENSTILAR calcipotriene and betamethasone dipropionate LEO Pharma Inc. NDA Current