Home Applications 208589 Application 208589
Type ANDA
Sponsor TELIGENT PHARMA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE OINTMENT;TOPICAL 0.05% No No
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 A208589-001 CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2019-01-23
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 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2019-01-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2019-01-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2019-01-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2019-01-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2019-01-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2019-01-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2019-01-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2019-01-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2019-01-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2019-01-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2019-01-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2019-01-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2019-01-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2019-01-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2019-01-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2019-01-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2019-01-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2019-01-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2019-01-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2019-01-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2019-01-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2019-01-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2019-01-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2019-01-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2019-01-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2019-01-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2019-01-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2019-01-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2019-01-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2019-01-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2019-01-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 2019-01-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2019-01-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2019-01-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2019-01-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2019-01-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2019-01-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2019-01-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2019-01-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208589-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2019-01-23 cb3db0bc1861…
Observed Orange Book normalized TE 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 6 · 108 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE Alembic Pharmaceuticals Inc. a83d212b-a970-4ee7-8431-fead6b2e7f9d 2026-07-17 Warnings, Adverse reactions Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE AvKARE a86241e0-3187-e468-e053-2995a90a1ae5 2026-07-15 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Sun Pharmaceutical Industries, Inc. d8f560c8-e223-46f0-8afb-b418f2b6399c 2026-07-14 Warnings, Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE OINTMENT USP, 0.05% Encube Ethicals, Inc. 1f076779-3f76-47d5-99f0-9b0b2d3f5fac 2026-07-09 Adverse reactions Name fallback brand name: Clobetasol Propionate CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE Alembic Pharmaceuticals Inc. 91e7bf57-d236-4b9b-8241-e71e5e93617a 2026-07-09 Warnings, Adverse reactions Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE A-S Medication Solutions 446209ba-61ad-46b5-99f7-039ae7fca757 2026-07-06 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE A-S Medication Solutions 8da21ad7-4d2d-4168-82ee-ebf13ce5e923 2026-06-23 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Torrent Pharmaceuticals Limited 6f930298-e410-4bfb-8c3f-456a1f55f4a9 2026-05-08 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE Golden State Medical Supply, Inc. 04180cdf-c63a-d524-e063-6394a90a2d06 2026-04-23 Adverse reactions Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE Clobetasol Propionate (emollient) CLOBETASOL PROPIONATE Bryant Ranch Prepack cb0bc057-d6ab-4eea-af7a-01661ae9b517 2026-04-23 Warnings, Adverse reactions Name fallback generic name: CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE A-S Medication Solutions c26e6e8f-9670-48c5-917b-e73e5589579a 2026-04-14 Adverse reactions Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE OINTMENT, 0.05% Preferred Pharmaceuticals Inc. 087c5aee-d7fd-42ce-b213-14c810292808 2026-03-30 Adverse reactions Name fallback brand name: Clobetasol Propionate Clobetasol Propionate CLOBETASOL PROPIONATE Sun Pharmaceutical Industries, Inc. 4a761afb-a48a-4a5a-8700-ad93601a260f 2026-03-23 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE Micro Labs Limited 85aea21d-c4ff-4558-b416-516fa93bea1f 2026-03-16 Adverse reactions Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE NorthStar RxLLC 3d14fff7-f1af-4d15-96b4-88cfccad271f 2026-02-11 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE clobetasol propionate CLOBETASOL PROPIONATE Glenmark Pharmaceuticals Inc., USA 6a3ad15e-2874-40d0-9e69-105b369c8cfc 2026-01-31 Warnings, Adverse reactions Name fallback brand name: clobetasol propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Glenmark Pharmaceuticals Inc., USA db8c7a36-e950-44b9-b2ff-7fede2e87407 2026-01-29 Warnings, Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Glenmark Pharmaceutcials Inc., USA 69794e0b-2a79-419e-844f-ed051be62249 2026-01-28 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC 736325f3-a369-4d70-b608-3d6ba37b6a6b 2026-01-28 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE BYQLOVI CLOBETASOL PROPIONATE Harrow Eye, LLC 31ca5a0f-812e-491d-aa00-d8ed424ba322 2026-01-26 Warnings, Adverse reactions Name fallback generic name: CLOBETASOL PROPIONATE
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 52565-039 Clobetasol Propionate Clobetasol Propionate Teligent Pharma, Inc. ANDA Current 52565-039 Clobetasol Propionate Clobetasol Propionate Teligent Pharma, Inc. ANDA Current 52565-039 Clobetasol Propionate Clobetasol Propionate Teligent Pharma, Inc. ANDA Current 70512-020 Clobetasol Propionate Oint 0.05% Clobetasol Propionate Oint 0.05% Sola Pharmaceuticals ANDA Current 70512-020 Clobetasol Propionate Oint 0.05% Clobetasol Propionate Oint 0.05% Sola Pharmaceuticals ANDA Current 72275-717 Clobetavix Clobetasol Propionate, Hydrocolloid Primary Pharmaceuticals, Inc ANDA Current