Application 213139

Type: ANDA
Sponsor: PRINSTON INC

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
A213139-001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL			2021-02-08

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2021-02-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2021-02-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2021-02-08	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2021-02-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2021-02-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2021-02-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2021-02-08	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL	AT	2021-02-08	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213139-001	CLOBETASOL PROPIONATE	0.05%	SOLUTION / TOPICAL		2021-02-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213139-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213139-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213139-001	AT	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213139-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213139-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213139-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213139-001	AT	1	`5aa47cf7b7d7…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213139-001	AT	1	`cb3db0bc1861…`

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 2 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	A-S Medication Solutions	c26e6e8f-9670-48c5-917b-e73e5589579a	2026-04-14	Adverse reactions	Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT, 0.05%	Preferred Pharmaceuticals Inc.	087c5aee-d7fd-42ce-b213-14c810292808	2026-03-30	Adverse reactions	Name fallback brand name: Clobetasol Propionate
Clobetasol Propionate	CLOBETASOL PROPIONATE	Sun Pharmaceutical Industries, Inc.	4a761afb-a48a-4a5a-8700-ad93601a260f	2026-03-23	Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Micro Labs Limited	85aea21d-c4ff-4558-b416-516fa93bea1f	2026-03-16	Adverse reactions	Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	NorthStar RxLLC	3d14fff7-f1af-4d15-96b4-88cfccad271f	2026-02-11	Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
clobetasol propionate	CLOBETASOL PROPIONATE	Glenmark Pharmaceuticals Inc., USA	6a3ad15e-2874-40d0-9e69-105b369c8cfc	2026-01-31	Warnings, Adverse reactions	Name fallback brand name: clobetasol propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Glenmark Pharmaceuticals Inc., USA	db8c7a36-e950-44b9-b2ff-7fede2e87407	2026-01-29	Warnings, Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Glenmark Pharmaceutcials Inc., USA	69794e0b-2a79-419e-844f-ed051be62249	2026-01-28	Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	736325f3-a369-4d70-b608-3d6ba37b6a6b	2026-01-28	Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
BYQLOVI	CLOBETASOL PROPIONATE	Harrow Eye, LLC	31ca5a0f-812e-491d-aa00-d8ed424ba322	2026-01-26	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE USP, 0.05%	A-S Medication Solutions	485e931d-16a7-4e92-996e-d3b32d9f41e7	2025-12-06	Adverse reactions	Name fallback brand name: Clobetasol Propionate
Clobetasol Propionate	CLOBETASOL PROPIONATE	NuCare Pharmaceuticals, Inc.	4524d04c-de48-6671-e063-6294a90a0e33	2025-12-04	Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
clobetasol propionate	CLOBETASOL PROPIONATE	Padagis Israel Pharmaceuticals Ltd	49bfff2e-9e4d-48a4-9f74-d6cf5b312aca	2025-11-30	Warnings, Adverse reactions	Name fallback brand name: clobetasol propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	4990e4c7-78b3-4bc8-85d0-6d58f08121ff	2025-11-04	Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
clobetasol propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	40c3b94f-a61c-4fc1-a411-5bf4e3fe6791	2025-10-21	Warnings, Adverse reactions	Name fallback brand name: clobetasol propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Lupin Pharmaceuticals, Inc.	0a267001-0bff-471c-8852-808e6e3ea37c	2025-10-14	Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Lupin Pharmaceuticals, Inc.	93f3763f-9f2f-4e81-bf6c-db35af45cd64	2025-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	f0ca99cd-6c54-44f8-a9b3-432e93fc5d59	2025-10-08	Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate (emollient)	CLOBETASOL PROPIONATE	The J. Molner Company LLC	26ccb1d8-c466-e238-e063-6394a90a0069	2025-10-02	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	9856b731-0676-405d-817c-de385cbd08a3	2025-09-30	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.