Application 211464

Type: ANDA
Sponsor: PERRIGO ISRAEL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HALOBETASOL PROPIONATE	HALOBETASOL PROPIONATE	LOTION;TOPICAL	0.05%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A211464-001	HALOBETASOL PROPIONATE	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL			2020-06-03

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211464-001	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL	2020-06-03	`a50c72e98297…`

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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64418	ORIG	2020-08-26
56873	ORIG	2018-12-20