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 43 .
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 · 43 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 2026-09-14 22:38:34 2026-08 A078854-001 CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL 2011-06-07 84e616aacf4f…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…
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 6 of 6 · 107 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE Glenmark Pharmaceuticals Inc., USA dfc58f73-e892-4fc3-8726-4e8d1546ebd3 2020-09-07 Warnings, Adverse reactions Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Glenmark Pharmaceuticals Inc., USA 420deed6-321f-4a2a-9042-1e61636621aa 2020-08-26 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Actavis Pharma, Inc. afd20e23-b7a6-46ca-bd8d-b7af9ff84201 2020-02-29 Warnings, Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE clobetasol propionate CLOBETASOL PROPIONATE Lupin Pharmaceuticals,Inc. 3e0fe7b1-f511-491f-b74d-3ca00449835b 2018-08-10 Adverse reactions Name fallback brand name: clobetasol propionate generic name: CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE Glenmark Pharmaceuticals Inc., USA e37dd885-889a-4bfd-9813-bb7b9b96cee1 2018-04-18 Adverse reactions Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE clobetasol propionate CLOBETASOL PROPIONATE Novel Laboratories, Inc. c7c03887-f84a-417e-a8f1-5272f530d0bb 2016-05-21 Adverse reactions Name fallback brand name: clobetasol propionate generic name: CLOBETASOL PROPIONATE clobetasol propionate CLOBETASOL PROPIONATE Novel Laboratories, Inc. afa1c879-36b9-401e-85d4-638ceec8f444 2016-04-28 Adverse reactions Name fallback brand name: clobetasol propionate generic name: CLOBETASOL PROPIONATE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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