Last Updated: September 24, 2026

Details for New Drug Application (NDA): 203098

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NDA 203098 describes TESTOSTERONE, which is a drug marketed by Actavis Labs Ut Inc, Alembic, Amneal, Encube, Lupin, Padagis Israel, Perrigo Israel, Twi Pharms, Xiromed, Ani Pharms, Strides Pharma Intl, Dr Reddys, Watson Labs, Apotex, Cipla, Am Regent, Caplin One Labs, Eugia Pharma, Hikma, Hikma Farmaceutica, Padagis Us, Rising, Sun Pharm Inds Ltd, Watson Pharms Inc, Wilshire Pharms Inc, Nexus, Bel Mar, Elkins Sinn, and Lilly, and is included in fifty-nine NDAs. It is available from twelve suppliers. Additional details are available on the TESTOSTERONE profile page.

The generic ingredient in TESTOSTERONE is testosterone propionate. There are six drug master file entries for this compound. Additional details are available on the testosterone propionate profile page.

Summary for 203098

Tradename:	TESTOSTERONE
Applicant:	Perrigo Israel
Ingredient:	testosterone
Patents:	0

Medical Subject Heading (MeSH) Categories for 203098

Androgens

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GEL, METERED;TRANSDERMAL			Strength	12.5MG/1.25GM ACTUATION
Approval Date:	Jan 31, 2013	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GEL;TRANSDERMAL			Strength	25MG/2.5GM PACKET
Approval Date:	Jan 31, 2013	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GEL;TRANSDERMAL			Strength	50MG/5GM PACKET
Approval Date:	Jan 31, 2013	TE:		RLD:	No

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