Last Updated: November 8, 2026

Details for New Drug Application (NDA): 207373

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NDA 207373 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, Bpi Labs, 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 sixty 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 207373

Tradename:	TESTOSTERONE
Applicant:	Amneal
Ingredient:	testosterone
Patents:	0

Pharmacology for NDA: 207373

Mechanism of Action	Androgen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 207373

Androgens

Suppliers and Packaging for NDA: 207373

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TESTOSTERONE	testosterone	GEL, METERED;TRANSDERMAL	207373	ANDA	Amneal Pharmaceuticals NY LLC	69238-1013	69238-1013-2	1 BOTTLE, PUMP in 1 CARTON (69238-1013-2) / 88 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL, METERED;TRANSDERMAL			Strength	1.62% (20.25MG/1.25GM ACTUATION)
Approval Date:	Apr 10, 2019	TE:	AB	RLD:	No

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