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 4 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 Limited 96f20fcd-aa96-4472-807b-43094befc8a9 2025-02-10 Warnings, Adverse reactions Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Macleods Pharmaceuticals Limited 44ced6ce-fa10-426d-a498-a13b8b34f49a 2025-01-29 Warnings, Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE DIRECT RX cc716dab-b535-8b51-e053-2995a90a8f16 2025-01-20 Adverse reactions Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE Tovet (emollient formulation) CLOBETASOL PROPIONATE Medimetriks Pharmaceuticals, Inc. 4d5c5b14-9e4f-4d43-a336-e4ae71d34e42 2024-12-12 Warnings, Adverse reactions Name fallback generic name: CLOBETASOL PROPIONATE clobetasol propionate CLOBETASOL PROPIONATE Zydus Lifesciences Limited 287ce325-4449-4342-a9ef-a7e31ee692bd 2024-11-26 Name fallback brand name: clobetasol propionate generic name: CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE Zydus Lifesciences Limited 30f4c173-189d-4b29-8d7d-e82e5c0743cf 2024-11-26 Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Bryant Ranch Prepack 1bdc1978-00d1-43f4-a127-a9d9c709644d 2024-10-30 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Viona Pharmaceuticals Inc 2fc7de5f-094f-400c-b87e-750b16046f46 2024-08-16 Warnings, Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Zydus Lifesciences Limited d01b8f72-c2d2-49d8-87d7-3d60f11a7bbb 2024-08-14 Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE OINTMENT USP, 0.05% Bryant Ranch Prepack c57776d2-06d7-4019-95df-ff38f721dec5 2024-04-12 Adverse reactions Name fallback brand name: Clobetasol Propionate CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE Alembic Pharmaceuticals Inc. 0ccf8ddd-5fd8-48c7-97c9-5450a39c1bcb 2024-03-14 Adverse reactions Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Proficient Rx LP e0f7bc85-9c13-44df-9b37-c216ecfe3ffe 2024-03-01 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE Aurobindo Pharma Limited e238bf90-f5fd-446d-9799-e8f8fed2f0a9 2024-02-28 Adverse reactions Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE Impoyz CLOBETASOL PROPIONATE Primus Pharmaceuticals, Inc. 40173654-334e-4618-847b-6a1e030cd2fd 2024-01-30 Warnings, Adverse reactions Name fallback generic name: CLOBETASOL PROPIONATE clobetasol propionate CLOBETASOL PROPIONATE Lupin Pharmaceuticals,Inc. c6efb5f3-3532-4742-a359-3991bb76338f 2024-01-29 Adverse reactions Name fallback brand name: clobetasol propionate generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE Bryant Ranch Prepack a178bb79-c0dc-4561-93df-8f7bd9d57bae 2024-01-12 Warnings, Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE Quagen Pharmaceuticals LLC 5f6d2a57-92c9-4568-83d1-524de42182b4 2024-01-10 Adverse reactions Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE Clobetasol Propionate ANDA CLOBETASOL PROPIONATE Macleods Pharmaceuticals Limited 92cf4231-e301-4353-98d9-85206ec6ba96 2024-01-05 Adverse reactions Name fallback generic name: CLOBETASOL PROPIONATE Clobetasol Propionate CLOBETASOL PROPIONATE A-S Medication Solutions 846f1ae1-0a7f-4609-b1a0-c749ffc79ce8 2024-01-02 Adverse reactions Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE Alembic Pharmaceuticals Inc. a75cac17-c0d1-403a-8a63-80b2d43e3169 2023-12-12 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