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 5 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 Alembic Pharmaceuticals Inc. 0d5ca826-d200-42d8-b9c7-d05ecabb6ab2 2023-12-08 Warnings, Adverse reactions Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Cosette Pharmaceuticals, Inc. 807d6a1a-4eca-9cf4-f514-bb1cd7b10d0f 2023-11-28 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clodan CLOBETASOL PROPIONATE Medimetriks Pharmaceuticals b5d32546-65dc-4b0c-826e-ddbc2a50b152 2023-11-20 Warnings, Adverse reactions Name fallback generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE A-S Medication Solutions e223598e-3cf8-4362-b963-a23ea05072ba 2023-10-16 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE clobetasol propionate CLOBETASOL PROPIONATE Mayne Pharma Inc. 524397b3-84c4-49d7-af5e-bb229dfee68b 2023-08-16 Warnings, Adverse reactions Name fallback brand name: clobetasol propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE A-S Medication Solutions 52bf5318-2487-4c7b-aa8d-e98f22cc6104 2023-07-27 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE A-S Medication Solutions ecef6314-97c0-4f2e-bbcb-53a62ac7fb72 2023-07-27 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Bryant Ranch Prepack bc021c6c-43db-469c-b1c3-0166b18daea4 2023-07-17 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Bryant Ranch Prepack 695b2b8a-9d8c-4e94-bc78-2f535b8e2cbc 2023-07-17 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE AvKARE a862de41-1500-9136-e053-2a95a90a6080 2023-07-03 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE A-S Medication Solutions f8e06ea9-bd18-48db-9f53-8e75734c8f01 2023-03-27 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Padagis Israel Pharmaceuticals Ltd f9df643a-015d-4101-ac8f-c1e05b052df5 2023-03-01 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Macleods Pharmaceuticals Limited 5ad9c808-6095-4d86-b140-e0f6d4079a3a 2022-12-23 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE clobetasol propionate CLOBETASOL PROPIONATE Zydus Pharmaceuticals USA Inc. 8618a3bc-5601-4273-a708-27b0ecd4c385 2022-10-06 Warnings, Adverse reactions Name fallback brand name: clobetasol propionate generic name: CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE Zydus Pharmaceuticals USA Inc. 98a25409-e84e-452b-8dc5-ad87842398e1 2022-10-05 Adverse reactions Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE clobetasol propionate emollient formulation CLOBETASOL PROPIONATE Padagis Israel Pharmaceuticals Ltd 5264dfb8-3f6f-4f20-958d-9b5855806dc8 2022-03-31 Warnings, Adverse reactions Name fallback generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Padagis Israel Pharmaceuticals Ltd 3f75880b-9ead-4c6e-b999-3bd7e1643ce5 2022-03-31 Warnings, Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate (emollient) CLOBETASOL PROPIONATE E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. fdfd83ee-dfb4-4c12-a74e-a0053e34e08c 2021-07-01 Warnings, Adverse reactions Name fallback generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Northstar Rx LLC 0d0e8e82-2b57-4cc0-a46b-bd08fb581deb 2021-05-31 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Xiromed, LLC 56e6d233-d9ee-f022-3be7-d100799a561e 2020-11-06 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