Application 210638

Type: ANDA
Sponsor: XIROMED

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	AEROSOL, FOAM;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
A210638-001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL	AB1		2025-11-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A210638-001	AB1

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	A210638-001	CLOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL	AB1	2025-11-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210638-001	CLOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL	AB1	2025-11-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210638-001	CLOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL	AB1	2025-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210638-001	CLOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL	AB1	2025-11-20	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210638-001	CLOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL	AB1	2025-11-20	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A210638-001	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210638-001	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210638-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210638-001	AB1	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210638-001	AB1	1	`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 3 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	Bryant Ranch Prepack	643682ee-39c8-4a0d-b131-f30077e6e20a	2025-09-03	Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	21a63bc2-a42a-412c-8dd5-17e279f99f27	2025-09-03	Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	6d14d269-bae6-493a-81ed-83f6a3aa0f4f	2025-09-03	Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Sun Pharmaceutical Industries, Inc.	91571297-03ad-441e-8ec6-f78c21fbe5e8	2025-08-22	Warnings, Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Xiromed, LLC	2556987f-4b0f-8a83-5bf4-095d67a450b4	2025-08-12	Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	NORTHSTAR RX LLC	72c90da7-5f6a-4b8d-875d-f07ceeec295e	2025-07-09	Warnings, Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	2d4fa3a3-dc1c-4d3c-9959-4751e09d25be	2025-07-08	Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Sun Pharmaceutical Industries, Inc.	04d7d65b-d7ed-4223-abab-5d0aed36a155	2025-07-07	Warnings, Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Sun Pharmaceutical Industries, Inc.	d4c73fb0-9675-4c41-a8bd-dd4cb2db1169	2025-07-07	Warnings, Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Sun Pharmaceutical Industries, Inc.	f5ea346b-f507-4224-88a6-4c891c4b1ad5	2025-07-03	Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Sun Pharmaceutical Industries, Inc.	d8246614-757b-4e27-8c3e-37fcb401e6d9	2025-07-03	Warnings, Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Alembic Pharmaceuticals Limited	6fc0d1ac-f357-4038-8004-263bfaed4eaf	2025-04-25	Warnings, Adverse reactions	Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Eyenovia, Inc.	7687c980-7006-4222-80b9-c32773772d3e	2025-04-16	Warnings, Adverse reactions	Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE
clobetasol propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	2d0b48d9-dbfb-4265-b73b-07faf217ae6e	2025-04-02	Warnings, Adverse reactions	Name fallback brand name: clobetasol propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Alembic Pharmaceuticals Inc.	fc3ac7b5-0cd5-4d31-97e4-b01c0f715835	2025-03-28	Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Alembic Pharmaceuticals Limited	a4f74fc7-d2f6-4cf2-9cc5-60078bde55a7	2025-03-26	Adverse reactions	Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Alembic Pharmaceuticals Limited	46bda1db-c2eb-461a-bcd0-dfdb6c7f542d	2025-03-18	Adverse reactions	Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Alembic Pharmaceuticals Limited	2b7f0643-679c-4586-a3a0-31eae4a36f19	2025-03-18	Warnings, Adverse reactions	Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	INA Pharmaceutics Inc	1b0e9eb5-71eb-44b4-894a-094a9f325dc8	2025-02-13	Warnings, Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Alembic Pharmaceuticals Limited	1a4331e1-5c79-44c3-a691-4b808a3bde97	2025-02-12	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.