An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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-Package Insert, Labeling-Medication Guide		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
ANDROGEL	TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET)	GEL;TRANSDERMAL	Prescription	Yes	AB2	022309	BESINS HLTHCARE
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
ANDROGEL	TESTOSTERONE	1.62% (40.5MG/2.5GM PACKET)	GEL;TRANSDERMAL	Prescription	Yes	AB2	022309	BESINS HLTHCARE
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

Top