Home Applications 209974 Application 209974
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 CREAM;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 A209974-001 CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL 2018-04-17
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 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL 2018-04-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL 2018-04-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL 2018-04-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL 2018-04-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL 2018-04-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL 2018-04-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL 2018-04-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL 2018-04-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL 2018-04-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL 2018-04-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL 2018-04-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL 2018-04-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL 2018-04-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL 2018-04-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2018-04-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2018-04-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2018-04-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2018-04-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2018-04-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2018-04-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2018-04-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2018-04-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2018-04-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2018-04-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2018-04-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2018-04-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2018-04-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL 2018-04-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL 2018-04-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL 2018-04-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL 2018-04-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL 2018-04-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2018-04-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2018-04-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2018-04-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2018-04-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2018-04-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2018-04-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2018-04-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209974-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2018-04-17 cb3db0bc1861…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 · 19 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50090-3820 Clobetasol Propionate Clobetasol Propionate A-S Medication Solutions ANDA Current 50090-3820 Clobetasol Propionate Clobetasol Propionate A-S Medication Solutions ANDA Current 50090-3820 Clobetasol Propionate Clobetasol Propionate A-S Medication Solutions ANDA Current 52565-051 Clobetasol Propionate Clobetasol Propionate Teligent Pharma, Inc. ANDA Current 52565-051 Clobetasol Propionate Clobetasol Propionate Teligent Pharma, Inc. ANDA Current 59088-744 Clobetair Clobetair PureTek Corporation ANDA Current 59088-751 Tasoprol Tasoprol PureTek Corporation ANDA Current 59088-762 Clobetex Clobetasol Propionate PureTek Corporation ANDA Current 59088-762 Clobetex Clobetasol Propionate PureTek Corporation ANDA Current 68071-4592 Clobetasol Propionate Clobetasol Propionate NuCare Pharmaceuticals,Inc. ANDA Current 68788-7212 Clobetasol Propionate Clobetasol Propionate Preferred Pharmaceuticals Inc. ANDA Current 68788-7212 Clobetasol Propionate Clobetasol Propionate Preferred Pharmaceuticals Inc. ANDA Current 68788-7212 Clobetasol Propionate Clobetasol Propionate Preferred Pharmaceuticals Inc. ANDA Current 68788-7212 Clobetasol Propionate Clobetasol Propionate Preferred Pharmaceuticals Inc. ANDA Current 70512-028 Clobetasol Propionate Cream Clobetasol Propionate Cream Sola Pharmaceuticals ANDA Current 70512-028 Clobetasol Propionate Cream Clobetasol Propionate Cream Sola Pharmaceuticals ANDA Current 70512-028 Clobetasol Propionate Cream Clobetasol Propionate Cream Sola Pharmaceuticals ANDA Current 70512-028 Clobetasol Propionate Cream Clobetasol Propionate Cream Sola Pharmaceuticals ANDA Current 70512-028 Clobetasol Propionate Cream Clobetasol Propionate Cream Sola Pharmaceuticals ANDA Current