Home Applications 078854 Application 078854
Type ANDA
Sponsor ACTAVIS MID ATLANTIC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE SHAMPOO;TOPICAL 0.05% No No
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 A078854-001 CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL 2011-06-07
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 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL 2011-06-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL 2011-06-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL 2011-06-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL 2011-06-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL 2011-06-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL 2011-06-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL 2011-06-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL 2011-06-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL 2011-06-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL 2011-06-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL 2011-06-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL 2011-06-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL 2011-06-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL 2011-06-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL 2011-06-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL AB 2011-06-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL AB 2011-06-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL AB 2011-06-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL AB 2011-06-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL AB 2011-06-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL AB 2011-06-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL AB 2011-06-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL AB 2011-06-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL AB 2011-06-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL AB 2011-06-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL AB 2011-06-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL AB 2011-06-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL AB 2011-06-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL 2011-06-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL 2011-06-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL 2011-06-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL 2011-06-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL 2011-06-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL AB 2011-06-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL AB 2011-06-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL AB 2011-06-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL AB 2011-06-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL AB 2011-06-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL AB 2011-06-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL AB 2011-06-07 e64feba35796…
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 OINTMENT USP, 0.05% Bryant Ranch Prepack d6a0f4ca-dd42-4af3-85e5-8c61c0ba6ae2 2026-08-07 Adverse reactions Name fallback brand name: Clobetasol Propionate Clobetasol Propionate CLOBETASOL PROPIONATE OINTMENT USP, 0.05% Bryant Ranch Prepack 032f1f4e-1f1c-409a-8fac-6449ee543caa 2026-08-07 Adverse reactions Name fallback brand name: Clobetasol Propionate Clobetasol Propionate CLOBETASOL PROPIONATE OINTMENT USP, 0.05% Bryant Ranch Prepack 3dcc49e7-a4f8-44cf-9405-2786bdc910cb 2026-08-06 Adverse reactions Name fallback brand name: Clobetasol Propionate 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 Amneal Pharmaceuticals NY LLC 4363539b-d25e-4da3-911c-9ba142d7f4f4 2026-06-19 Warnings, 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 Encube Ethicals, Inc. 8ad5f9b0-b50a-4d1f-a0c1-704b5b72bf65 2026-04-21 Adverse reactions Name fallback brand name: CLOBETASOL PROPIONATE 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
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0472-0403 Clobetasol Propionate Clobetasol Propionate Actavis Pharma, Inc. ANDA Current 0472-0403 Clobetasol Propionate Clobetasol Propionate Actavis Pharma, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 31391 ORIG 2011-06-09