Home Applications 077001 Application 077001
Type ANDA
Sponsor FOUGERA PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HALOBETASOL PROPIONATE HALOBETASOL PROPIONATE CREAM;TOPICAL 0.05% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A077001-001 HALOBETASOL PROPIONATE HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077001-001 AB
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077001-001 HALOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB 2004-12-16 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 1 · 17 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Halobetasol Propionate HALOBETASOL PROPIONATE Coral Way Pharma, LLC 4cb1f7b3-c412-6fc7-e063-6394a90a63c9 2026-06-29 Warnings, Adverse reactions Name fallback brand name: Halobetasol Propionate generic name: HALOBETASOL PROPIONATE Halobetasol Propionate HALOBETASOL PROPIONATE Encube Ethicals, Inc. d4f03a79-3d5e-4a39-8ab0-8ebd3d804e39 2026-06-29 Adverse reactions Name fallback brand name: Halobetasol Propionate generic name: HALOBETASOL PROPIONATE Halobetasol Propionate HALOBETASOL PROPIONATE Bryant Ranch Prepack e408184b-0545-4728-9f95-90d8cdec544a 2026-04-23 Adverse reactions Name fallback brand name: Halobetasol Propionate generic name: HALOBETASOL PROPIONATE LEXETTE HALOBETASOL PROPIONATE Mayne Pharma 8aa1f819-c81f-4af1-aaa7-353df3203ff6 2025-05-31 Warnings, Adverse reactions Name fallback generic name: HALOBETASOL PROPIONATE ULTRAVATE HALOBETASOL PROPIONATE Lacer Pharma, LLC 74e899db-1c1f-48b2-9913-5d32a14906ae 2025-04-06 Warnings, Adverse reactions Name fallback generic name: HALOBETASOL PROPIONATE Halobetasol Propionate HALOBETASOL PROPIONATE Bryant Ranch Prepack 83725d7b-0788-4903-a75a-8e318ee7b568 2024-10-24 Adverse reactions Name fallback brand name: Halobetasol Propionate generic name: HALOBETASOL PROPIONATE Halobetasol Propionate HALOBETASOL PROPIONATE Bryant Ranch Prepack e78c7fc9-34ba-4162-a98e-78931dc31dab 2024-08-22 Adverse reactions Name fallback brand name: Halobetasol Propionate generic name: HALOBETASOL PROPIONATE Halobetasol Propionate HALOBETASOL PROPIONATE Bryant Ranch Prepack 14766ad1-d61d-4838-92e1-849a929f4dbd 2024-05-29 Adverse reactions Name fallback brand name: Halobetasol Propionate generic name: HALOBETASOL PROPIONATE Halobetasol Propionate HALOBETASOL PROPIONATE Cosette Pharmaceuticals, Inc. f12ff257-dd77-4f9c-97c4-339784772d9f 2024-04-16 Adverse reactions Name fallback brand name: Halobetasol Propionate generic name: HALOBETASOL PROPIONATE Halobetasol Propionate HALOBETASOL PROPIONATE Bryant Ranch Prepack be683823-9c07-498c-8357-71cbb3a3964c 2024-03-11 Adverse reactions Name fallback brand name: Halobetasol Propionate generic name: HALOBETASOL PROPIONATE Halobetasol propionate HALOBETASOL PROPIONATE Mayne Pharma 24c41e6d-a314-4984-b45f-e5aa1fffa9b6 2023-11-30 Warnings, Adverse reactions Name fallback brand name: Halobetasol propionate generic name: HALOBETASOL PROPIONATE Halobetasol Propionate HALOBETASOL PROPIONATE Cosette Pharmaceuticals, Inc. 1f57aaae-8d5f-bfdf-08d6-495b84221311 2023-11-23 Adverse reactions Name fallback brand name: Halobetasol Propionate generic name: HALOBETASOL PROPIONATE Halobetasol Propionate HALOBETASOL PROPIONATE Bryant Ranch Prepack c4e78fa5-6ced-4c90-89c6-31e5fc71b837 2023-08-15 Adverse reactions Name fallback brand name: Halobetasol Propionate generic name: HALOBETASOL PROPIONATE Halobetasol Propionate HALOBETASOL PROPIONATE QUAGEN PHARMACEUTICALS LLC fd4ebec1-e5ba-46cc-9627-4645a7b3bf19 2023-02-02 Adverse reactions Name fallback brand name: Halobetasol Propionate generic name: HALOBETASOL PROPIONATE Halobetasol Propionate HALOBETASOL PROPIONATE Padagis Israel Pharmaceuticals Ltd c420da92-a3e3-4760-8cad-e50cbacebfeb 2022-12-31 Adverse reactions Name fallback brand name: Halobetasol Propionate generic name: HALOBETASOL PROPIONATE Halobetasol Propionate HALOBETASOL PROPIONATE Padagis Israel Pharmaceuticals Ltd df26430c-8182-4d03-a254-06d913de4c95 2022-12-01 Adverse reactions Name fallback brand name: Halobetasol Propionate generic name: HALOBETASOL PROPIONATE Bryhali HALOBETASOL PROPIONATE Bausch Health US, LLC d4bbb66a-3f9d-4091-b1b0-1cbc908432d3 2020-06-01 Warnings, Adverse reactions Name fallback generic name: HALOBETASOL PROPIONATE
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 0168-0355 Halobetasol Propionate halobetasol propionate Fougera Pharmaceuticals Inc. ANDA Current 0168-0355 Halobetasol Propionate halobetasol propionate E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. ANDA Current 0168-0355 Halobetasol Propionate halobetasol propionate Fougera Pharmaceuticals Inc. ANDA Current 63629-8735 Halobetasol Propionate halobetasol propionate Bryant Ranch Prepack ANDA Current 63629-8735 Halobetasol Propionate halobetasol propionate Bryant Ranch Prepack ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 8990 ORIG 2004-12-30