Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075368
Company: FOUGERA PHARMS

Products on ANDA 075368

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075368

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/15/2000	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75368ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/14/2006	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075368

CLOBETASOL PROPIONATE

GEL;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%	GEL;TOPICAL	Prescription	No	AB	075368	FOUGERA PHARMS
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	GEL;TOPICAL	Prescription	No	AB	075027	PADAGIS US
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	GEL;TOPICAL	Prescription	No	AB	075279	SUN PHARMA CANADA