Last Updated: September 24, 2026

Details for New Drug Application (NDA): 204571

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NDA 204571 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 204571

Tradename:	TESTOSTERONE
Applicant:	Actavis Labs Ut Inc
Ingredient:	testosterone
Patents:	0

Medical Subject Heading (MeSH) Categories for 204571

Androgens

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL, METERED;TRANSDERMAL			Strength	10MG/0.5GM ACTUATION
Approval Date:	Aug 5, 2015	TE:		RLD:	No

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