Details for New Drug Application (NDA): 204268

NDA 204268 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 204268

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

Pharmacology for NDA: 204268

Mechanism of Action

Androgen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 204268

Androgens

Suppliers and Packaging for NDA: 204268

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TESTOSTERONE	testosterone	GEL, METERED;TRANSDERMAL	204268	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-754	45802-754-01	1 BOTTLE, PUMP in 1 CARTON (45802-754-01) / 88 g in 1 BOTTLE, PUMP
TESTOSTERONE	testosterone	GEL, METERED;TRANSDERMAL	204268	ANDA	Bryant Ranch Prepack	63629-8455	63629-8455-1	1 BOTTLE, PUMP in 1 CARTON (63629-8455-1) / 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:	Aug 4, 2015	TE:	AB	RLD:	No

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