Home Applications 074331 Application 074331
Type ANDA
Sponsor ACP NIMBLE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE SOLUTION;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 A074331-001 CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 1995-12-15
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 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 1995-12-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 1995-12-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 1995-12-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 1995-12-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 1995-12-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 1995-12-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 1995-12-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 1995-12-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 1995-12-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 1995-12-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 1995-12-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 1995-12-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 1995-12-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 1995-12-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 1995-12-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 1995-12-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 1995-12-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 1995-12-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 1995-12-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 1995-12-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 1995-12-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 1995-12-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 1995-12-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 1995-12-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 1995-12-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 1995-12-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 1995-12-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 1995-12-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 1995-12-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 1995-12-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 1995-12-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 1995-12-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 1995-12-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 1995-12-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 1995-12-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 1995-12-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 1995-12-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 1995-12-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 1995-12-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074331-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 1995-12-15 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 3 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 Bryant Ranch Prepack 643682ee-39c8-4a0d-b131-f30077e6e20a 2025-09-03 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Bryant Ranch Prepack 21a63bc2-a42a-412c-8dd5-17e279f99f27 2025-09-03 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Bryant Ranch Prepack 6d14d269-bae6-493a-81ed-83f6a3aa0f4f 2025-09-03 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Sun Pharmaceutical Industries, Inc. 91571297-03ad-441e-8ec6-f78c21fbe5e8 2025-08-22 Warnings, Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Xiromed, LLC 2556987f-4b0f-8a83-5bf4-095d67a450b4 2025-08-12 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE NORTHSTAR RX LLC 72c90da7-5f6a-4b8d-875d-f07ceeec295e 2025-07-09 Warnings, Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 2d4fa3a3-dc1c-4d3c-9959-4751e09d25be 2025-07-08 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Sun Pharmaceutical Industries, Inc. 04d7d65b-d7ed-4223-abab-5d0aed36a155 2025-07-07 Warnings, Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Sun Pharmaceutical Industries, Inc. d4c73fb0-9675-4c41-a8bd-dd4cb2db1169 2025-07-07 Warnings, Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Sun Pharmaceutical Industries, Inc. f5ea346b-f507-4224-88a6-4c891c4b1ad5 2025-07-03 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Sun Pharmaceutical Industries, Inc. d8246614-757b-4e27-8c3e-37fcb401e6d9 2025-07-03 Warnings, Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE Alembic Pharmaceuticals Limited 6fc0d1ac-f357-4038-8004-263bfaed4eaf 2025-04-25 Warnings, Adverse reactions Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE Eyenovia, Inc. 7687c980-7006-4222-80b9-c32773772d3e 2025-04-16 Warnings, Adverse reactions Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE clobetasol propionate CLOBETASOL PROPIONATE Bryant Ranch Prepack 2d0b48d9-dbfb-4265-b73b-07faf217ae6e 2025-04-02 Warnings, Adverse reactions Name fallback brand name: clobetasol propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Alembic Pharmaceuticals Inc. fc3ac7b5-0cd5-4d31-97e4-b01c0f715835 2025-03-28 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE Alembic Pharmaceuticals Limited a4f74fc7-d2f6-4cf2-9cc5-60078bde55a7 2025-03-26 Adverse reactions Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE Alembic Pharmaceuticals Limited 46bda1db-c2eb-461a-bcd0-dfdb6c7f542d 2025-03-18 Adverse reactions Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE Alembic Pharmaceuticals Limited 2b7f0643-679c-4586-a3a0-31eae4a36f19 2025-03-18 Warnings, Adverse reactions Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE INA Pharmaceutics Inc 1b0e9eb5-71eb-44b4-894a-094a9f325dc8 2025-02-13 Warnings, Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Alembic Pharmaceuticals Limited 1a4331e1-5c79-44c3-a691-4b808a3bde97 2025-02-12 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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0472-0402 Clobetasol Propionate Clobetasol Propionate Actavis Pharma, Inc. ANDA Current 0472-0402 Clobetasol Propionate Clobetasol Propionate Actavis Pharma, Inc. ANDA Current 0472-0402 Clobetasol Propionate Clobetasol Propionate Actavis Pharma, Inc. ANDA Current 0472-0402 Clobetasol Propionate Clobetasol Propionate Actavis Pharma, Inc. ANDA Current 50090-3085 Clobetasol Propionate Clobetasol Propionate A-S Medication Solutions ANDA Current