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): 074407
Company: FOUGERA PHARMS

Products on ANDA 074407

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074407

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/23/1996	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/14/2006	SUPPL-7	Labeling		Label is not available on this site.
03/05/2001	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/05/2001	SUPPL-3	Labeling		Label is not available on this site.
05/08/1997	SUPPL-2	Labeling		Label is not available on this site.
12/15/1997	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 074407

CLOBETASOL PROPIONATE

OINTMENT;TOPICAL; 0.05%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	211800	ALEMBIC
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	075057	AUROBINDO PHARMA USA
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	074089	COSETTE PHARMS NC
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	211295	ENCUBE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	074407	FOUGERA PHARMS
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	215990	MACLEODS PHARMS LTD
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	208841	NOVEL LABS INC
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	074248	SUN PHARMA CANADA
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	209701	XIROMED
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	210199	ZYDUS PHARMS

Top