Last Updated: September 24, 2026

Details for New Drug Application (NDA): 091073

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NDA 091073 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 091073

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

Pharmacology for NDA: 091073

Mechanism of Action	Androgen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 091073

Androgens

Suppliers and Packaging for NDA: 091073

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TESTOSTERONE	testosterone	GEL;TRANSDERMAL	091073	ANDA	Actavis Pharma, Inc.	0591-3524	0591-3524-30	30 TUBE in 1 CARTON (0591-3524-30) / 5 g in 1 TUBE (0591-3524-26)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TRANSDERMAL			Strength	50MG/5GM PACKET
Approval Date:	Sep 18, 2017	TE:	AB2	RLD:	No

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