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 4 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	Alembic Pharmaceuticals Limited	96f20fcd-aa96-4472-807b-43094befc8a9	2025-02-10	Warnings, Adverse reactions	Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Macleods Pharmaceuticals Limited	44ced6ce-fa10-426d-a498-a13b8b34f49a	2025-01-29	Warnings, Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	DIRECT RX	cc716dab-b535-8b51-e053-2995a90a8f16	2025-01-20	Adverse reactions	Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE
Tovet (emollient formulation)	CLOBETASOL PROPIONATE	Medimetriks Pharmaceuticals, Inc.	4d5c5b14-9e4f-4d43-a336-e4ae71d34e42	2024-12-12	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
clobetasol propionate	CLOBETASOL PROPIONATE	Zydus Lifesciences Limited	287ce325-4449-4342-a9ef-a7e31ee692bd	2024-11-26		Name fallback brand name: clobetasol propionate generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Zydus Lifesciences Limited	30f4c173-189d-4b29-8d7d-e82e5c0743cf	2024-11-26		Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	1bdc1978-00d1-43f4-a127-a9d9c709644d	2024-10-30	Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Viona Pharmaceuticals Inc	2fc7de5f-094f-400c-b87e-750b16046f46	2024-08-16	Warnings, Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Zydus Lifesciences Limited	d01b8f72-c2d2-49d8-87d7-3d60f11a7bbb	2024-08-14		Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT USP, 0.05%	Bryant Ranch Prepack	c57776d2-06d7-4019-95df-ff38f721dec5	2024-04-12	Adverse reactions	Name fallback brand name: Clobetasol Propionate
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Alembic Pharmaceuticals Inc.	0ccf8ddd-5fd8-48c7-97c9-5450a39c1bcb	2024-03-14	Adverse reactions	Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Proficient Rx LP	e0f7bc85-9c13-44df-9b37-c216ecfe3ffe	2024-03-01	Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Aurobindo Pharma Limited	e238bf90-f5fd-446d-9799-e8f8fed2f0a9	2024-02-28	Adverse reactions	Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE
Impoyz	CLOBETASOL PROPIONATE	Primus Pharmaceuticals, Inc.	40173654-334e-4618-847b-6a1e030cd2fd	2024-01-30	Warnings, Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
clobetasol propionate	CLOBETASOL PROPIONATE	Lupin Pharmaceuticals,Inc.	c6efb5f3-3532-4742-a359-3991bb76338f	2024-01-29	Adverse reactions	Name fallback brand name: clobetasol propionate generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	a178bb79-c0dc-4561-93df-8f7bd9d57bae	2024-01-12	Warnings, Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Quagen Pharmaceuticals LLC	5f6d2a57-92c9-4568-83d1-524de42182b4	2024-01-10	Adverse reactions	Name fallback brand name: CLOBETASOL PROPIONATE generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate ANDA	CLOBETASOL PROPIONATE	Macleods Pharmaceuticals Limited	92cf4231-e301-4353-98d9-85206ec6ba96	2024-01-05	Adverse reactions	Name fallback generic name: CLOBETASOL PROPIONATE
Clobetasol Propionate	CLOBETASOL PROPIONATE	A-S Medication Solutions	846f1ae1-0a7f-4609-b1a0-c749ffc79ce8	2024-01-02	Adverse reactions	Name fallback brand name: Clobetasol Propionate generic name: CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Alembic Pharmaceuticals Inc.	a75cac17-c0d1-403a-8a63-80b2d43e3169	2023-12-12	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.