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): 075391
Company: FOUGERA PHARMS

Products on ANDA 075391

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075391

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/08/1999	ORIG-1	Approval			Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75391ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/075391_clobetasol_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/06/2019	SUPPL-12	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 075391

CLOBETASOL PROPIONATE

SOLUTION;TOPICAL; 0.05%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	212881	ALEMBIC
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	076977	ENCUBE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	075391	FOUGERA PHARMS
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	210190	GLENMARK PHARMS LTD
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	209361	MACLEODS PHARMS LTD
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	206075	NOVEL LABS INC
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	211240	QUAGEN
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	211494	SAPTALIS PHARMS
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	075224	TARO
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	075363	TARO

Top