Details for New Drug Application (NDA): 205328

NDA 205328 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, 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, Azurity, Nexus, Bel Mar, Elkins Sinn, and Lilly, and is included in sixty NDAs. It is available from fourteen suppliers. There are two patents protecting this drug. 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 205328

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

Pharmacology for NDA: 205328

Mechanism of Action

Androgen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 205328

Androgens

Suppliers and Packaging for NDA: 205328

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TESTOSTERONE	testosterone	SOLUTION, METERED;TRANSDERMAL	205328	ANDA	Actavis Pharma, Inc.	0591-2114	0591-2114-81	1 BOTTLE, WITH APPLICATOR in 1 CARTON (0591-2114-81) / 90 mL in 1 BOTTLE, WITH APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION, METERED;TRANSDERMAL			Strength	30MG/1.5ML ACTUATION
Approval Date:	Aug 7, 2017	TE:	AT	RLD:	No

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