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Last Updated: December 30, 2025

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, Lupin Ltd, Am Regent, Eugia Pharma, Hikma, Hikma Farmaceutica, Padagis Us, Rising, Sandoz, 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 thirteen suppliers. Additional details are available on the TESTOSTERONE profile page.

The generic ingredient in TESTOSTERONE is testosterone propionate. There are sixty-nine 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

Pharmacology for NDA: 204571

Mechanism of Action	Androgen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 204571

Androgens

Suppliers and Packaging for NDA: 204571

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TESTOSTERONE	testosterone	GEL, METERED;TRANSDERMAL	204571	ANDA	Actavis Pharma, Inc.	0591-2363	0591-2363-60	1 CANISTER in 1 CARTON (0591-2363-60) / 60 g in 1 CANISTER

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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