Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076668
Company: PADAGIS ISRAEL

Products on ANDA 076668

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.005%	OINTMENT;TOPICAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076668

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)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76668ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/08/2023	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
02/16/2017	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076668

FLUTICASONE PROPIONATE

OINTMENT;TOPICAL; 0.005%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.005%	OINTMENT;TOPICAL	Prescription	No	AB	077168	COSETTE
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.005%	OINTMENT;TOPICAL	Prescription	No	AB	076668	PADAGIS ISRAEL