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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207133
Company: PADAGIS ISRAEL

Products on ANDA 207133

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLURANDRENOLIDE	FLURANDRENOLIDE	0.05%	LOTION;TOPICAL	Prescription	AT	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207133

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/30/2016	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207133Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 207133

FLURANDRENOLIDE

LOTION;TOPICAL; 0.05%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLURANDRENOLIDE	FLURANDRENOLIDE	0.05%	LOTION;TOPICAL	Prescription	No	AT	207133	PADAGIS ISRAEL

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