Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091553
Company: PADAGIS ISRAEL

Products on ANDA 091553

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091553

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/30/2013	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
11/27/2019	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
11/27/2019	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091553

FLUTICASONE PROPIONATE

LOTION;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%	LOTION;TOPICAL	Prescription	No	AB	090759	GLENMARK PHARMS LTD
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05%	LOTION;TOPICAL	Prescription	No	AB	091553	PADAGIS ISRAEL