Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075279
Company: SUN PHARMA CANADA

Products on ANDA 075279

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075279

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/1999	ORIG-1	Approval			Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75279ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/075279_clobetasol_toc.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/06/2019	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
12/09/2002	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
12/09/2002	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/11/2001	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
12/23/1999	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 075279

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