An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 210638
Company: XIROMED

Products on ANDA 210638

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM;TOPICAL	Prescription	AB1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210638

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/20/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 210638

CLOBETASOL PROPIONATE

AEROSOL, FOAM;TOPICAL; 0.05%
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM;TOPICAL	Prescription	No	AB1	215838	ALEMBIC
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM;TOPICAL	Prescription	No	AB1	210809	GLENMARK PHARMS LTD
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM;TOPICAL	Prescription	No	AB1	077763	PADAGIS ISRAEL
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM;TOPICAL	Prescription	No	AB1	208779	TARO
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM;TOPICAL	Prescription	No	AB1	210638	XIROMED

Top