Details for New Drug Application (NDA): 210835

NDA 210835 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 210835

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

Pharmacology for NDA: 210835

Mechanism of Action

Androgen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 210835

Androgens

Suppliers and Packaging for NDA: 210835

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TESTOSTERONE	testosterone	GEL, METERED;TRANSDERMAL	210835	ANDA	Bryant Ranch Prepack	63629-2352	63629-2352-1	1 BOTTLE, PUMP in 1 CARTON (63629-2352-1) / 88 g in 1 BOTTLE, PUMP
TESTOSTERONE	testosterone	GEL, METERED;TRANSDERMAL	210835	ANDA	Xiromed, LLC	70700-112	70700-112-21	1 BOTTLE, PUMP in 1 CARTON (70700-112-21) / 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 16, 2020	TE:	AB	RLD:	No

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