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 42.

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
2026-08-18 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 1 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 OINTMENT USP, 0.05%	Bryant Ranch Prepack	7c71c9a8-9c76-4de4-982f-42eb54b7689c	2026-08-25	Adverse reactions	Name fallback brand name: Clobetasol Propionate
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT USP, 0.05%	Bryant Ranch Prepack	4d9b83e8-593e-4add-ac1d-c8eea25761bc	2026-08-25	Adverse reactions	Name fallback brand name: Clobetasol Propionate
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT USP, 0.05%	Bryant Ranch Prepack	fa0e3c04-4b45-4aca-8b59-7df2ec3963e7	2026-08-25	Adverse reactions	Name fallback brand name: Clobetasol Propionate
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT USP, 0.05%	Bryant Ranch Prepack	09717dc5-eef3-4f50-a346-f91d7e86fec9	2026-08-25	Adverse reactions	Name fallback brand name: Clobetasol Propionate
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT USP, 0.05%	Bryant Ranch Prepack	d6a0f4ca-dd42-4af3-85e5-8c61c0ba6ae2	2026-08-07	Adverse reactions	Name fallback brand name: Clobetasol Propionate
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT USP, 0.05%	Bryant Ranch Prepack	032f1f4e-1f1c-409a-8fac-6449ee543caa	2026-08-07	Adverse reactions	Name fallback brand name: Clobetasol Propionate
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT USP, 0.05%	Bryant Ranch Prepack	3dcc49e7-a4f8-44cf-9405-2786bdc910cb	2026-08-06	Adverse reactions	Name fallback brand name: Clobetasol Propionate
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Alembic Pharmaceuticals Inc.	a83d212b-a970-4ee7-8431-fead6b2e7f9d	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	AvKARE	a86241e0-3187-e468-e053-2995a90a1ae5	2026-07-15	Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Sun Pharmaceutical Industries, Inc.	d8f560c8-e223-46f0-8afb-b418f2b6399c	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT USP, 0.05%	Encube Ethicals, Inc.	1f076779-3f76-47d5-99f0-9b0b2d3f5fac	2026-07-09	Adverse reactions	Name fallback brand name: Clobetasol Propionate
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Alembic Pharmaceuticals Inc.	91e7bf57-d236-4b9b-8241-e71e5e93617a	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	A-S Medication Solutions	446209ba-61ad-46b5-99f7-039ae7fca757	2026-07-06	Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	A-S Medication Solutions	8da21ad7-4d2d-4168-82ee-ebf13ce5e923	2026-06-23	Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Amneal Pharmaceuticals NY LLC	4363539b-d25e-4da3-911c-9ba142d7f4f4	2026-06-19	Warnings, Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Torrent Pharmaceuticals Limited	6f930298-e410-4bfb-8c3f-456a1f55f4a9	2026-05-08	Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Golden State Medical Supply, Inc.	04180cdf-c63a-d524-e063-6394a90a2d06	2026-04-23	Adverse reactions	Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate (emollient)	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	cb0bc057-d6ab-4eea-af7a-01661ae9b517	2026-04-23	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Encube Ethicals, Inc.	8ad5f9b0-b50a-4d1f-a0c1-704b5b72bf65	2026-04-21	Adverse reactions	Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE
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