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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205781
Company: PADAGIS ISRAEL

Products on ANDA 205781

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TESTOSTERONE	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL;TRANSDERMAL	Prescription	AB2	No	No
TESTOSTERONE	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL;TRANSDERMAL	Prescription	AB2	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205781

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/12/2017	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205781Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205781Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/27/2019	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 205781

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/12/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205781Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 205781

TESTOSTERONE

GEL;TRANSDERMAL; 1.62% (20.25MG/1.25GM PACKET)
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TESTOSTERONE	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL;TRANSDERMAL	Prescription	No	AB2	204570	ACTAVIS LABS UT INC
TESTOSTERONE	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL;TRANSDERMAL	Prescription	No	AB2	205781	PADAGIS ISRAEL

GEL;TRANSDERMAL; 1.62% (40.5MG/2.5GM PACKET)
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TESTOSTERONE	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL;TRANSDERMAL	Prescription	No	AB2	204570	ACTAVIS LABS UT INC
TESTOSTERONE	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL;TRANSDERMAL	Prescription	No	AB2	205781	PADAGIS ISRAEL

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