Home Applications 209483 Application 209483
Type NDA
Sponsor ENCORE DERMAT Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IMPOYZ CLOBETASOL PROPIONATE CREAM;TOPICAL 0.025% 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 N209483-001 IMPOYZ CLOBETASOL PROPIONATE 0.025% CREAM / TOPICAL RLD, RS 2017-11-28
Orange Book patents# Current patent rows page 1 of 1 · 14 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209483-001 10064875 2030-08-31 U-1408 Drug product 2018-09-10 N209483-001 10064875 2030-08-31 U-1858 Drug product 2018-09-10 N209483-001 10064875 2030-08-31 U-193 Drug product 2018-09-10 N209483-001 10064875 2030-08-31 U-742 Drug product 2018-09-10 N209483-001 10064875 2030-08-31 U-88 Drug product 2018-09-10 N209483-001 10588914 2030-08-31 U-2771 Drug product 2020-04-08 N209483-001 11179465 2030-08-31 U-1858 Drug product 2026-03-03 N209483-001 9956231 2030-08-31 U-1408 Drug product 2018-05-21 N209483-001 9956231 2030-08-31 U-1761 Drug product 2018-05-21 N209483-001 9956231 2030-08-31 U-1858 Drug product 2018-05-21 N209483-001 9956231 2030-08-31 U-193 Drug product 2018-05-21 N209483-001 9956231 2030-08-31 U-742 Drug product 2018-05-21 N209483-001 9956231 2030-08-31 U-88 Drug product 2018-05-21 N209483-001 9855334 2035-03-11 Drug product 2018-01-04
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 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N209483-001 IMPOYZ 0.025% CREAM / TOPICAL RLD, RS 2017-11-28 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 14 · 530 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 N209483-001 10064875 2030-08-31 U-88 Drug product 2018-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209483-001 10064875 2030-08-31 U-1858 Drug product 2018-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209483-001 10064875 2030-08-31 U-193 Drug product 2018-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209483-001 10064875 2030-08-31 U-1408 Drug product 2018-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209483-001 10064875 2030-08-31 U-742 Drug product 2018-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209483-001 10588914 2030-08-31 U-2771 Drug product 2020-04-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209483-001 9956231 2030-08-31 U-88 Drug product 2018-05-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209483-001 9956231 2030-08-31 U-1408 Drug product 2018-05-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209483-001 9956231 2030-08-31 U-193 Drug product 2018-05-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209483-001 9956231 2030-08-31 U-742 Drug product 2018-05-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209483-001 9956231 2030-08-31 U-1858 Drug product 2018-05-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209483-001 9956231 2030-08-31 U-1761 Drug product 2018-05-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209483-001 9855334 2035-03-11 Drug product 2018-01-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209483-001 10064875 2030-08-31 U-88 Drug product 2018-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209483-001 10064875 2030-08-31 U-1858 Drug product 2018-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209483-001 10064875 2030-08-31 U-193 Drug product 2018-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209483-001 10064875 2030-08-31 U-1408 Drug product 2018-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209483-001 10064875 2030-08-31 U-742 Drug product 2018-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209483-001 10588914 2030-08-31 U-2771 Drug product 2020-04-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209483-001 9956231 2030-08-31 U-88 Drug product 2018-05-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209483-001 9956231 2030-08-31 U-1408 Drug product 2018-05-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209483-001 9956231 2030-08-31 U-193 Drug product 2018-05-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209483-001 9956231 2030-08-31 U-742 Drug product 2018-05-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209483-001 9956231 2030-08-31 U-1858 Drug product 2018-05-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209483-001 9956231 2030-08-31 U-1761 Drug product 2018-05-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209483-001 9855334 2035-03-11 Drug product 2018-01-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209483-001 10064875 2030-08-31 U-88 Drug product 2018-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209483-001 10064875 2030-08-31 U-1858 Drug product 2018-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209483-001 10064875 2030-08-31 U-193 Drug product 2018-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209483-001 10064875 2030-08-31 U-1408 Drug product 2018-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209483-001 10064875 2030-08-31 U-742 Drug product 2018-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209483-001 10588914 2030-08-31 U-2771 Drug product 2020-04-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209483-001 9956231 2030-08-31 U-88 Drug product 2018-05-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209483-001 9956231 2030-08-31 U-1408 Drug product 2018-05-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209483-001 9956231 2030-08-31 U-193 Drug product 2018-05-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209483-001 9956231 2030-08-31 U-742 Drug product 2018-05-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209483-001 9956231 2030-08-31 U-1858 Drug product 2018-05-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209483-001 9956231 2030-08-31 U-1761 Drug product 2018-05-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209483-001 9855334 2035-03-11 Drug product 2018-01-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209483-001 10064875 2030-08-31 U-88 Drug product 2018-09-10 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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 67857-811 IMPOYZ Clobetasol Propionate Promius Pharma, LLC. NDA Current 68040-713 Impoyz clobetasol propionate Primus Pharmaceuticals, Inc. NDA Current 69482-700 Impoyz clobetasol propionate Encore Dermatology, Inc NDA Current 69482-700 Impoyz clobetasol propionate Encore Dermatology, Inc NDA Current 69482-700 Impoyz clobetasol propionate Encore Dermatology, Inc NDA Current 69482-700 Impoyz clobetasol propionate Encore Dermatology, Inc NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 52959 ORIG 2018-03-14 50561 ORIG 2017-12-01 50524 ORIG 2017-11-29