Application 076903

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	OINTMENT;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
A076903-001	HALOBETASOL PROPIONATE	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL			2004-12-16

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076903-001	HALOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	2004-12-16	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0168-0356	Halobetasol Propionate	halobetasol propionate	E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8978	ORIG	2004-12-30