Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076633
Company: ENCUBE

Products on ANDA 076633

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076633

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/14/2004	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76633ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076633_ORIGINAL APPROVAL_PACKAGE.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/30/2012	SUPPL-16	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
02/24/2011	SUPPL-12	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076633

FLUTICASONE PROPIONATE

CREAM;TOPICAL; 0.05%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB	077055	COSETTE PHARMS NC
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB	076633	ENCUBE
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB	076451	FOUGERA PHARMS
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB	076793	PADAGIS ISRAEL