Details for New Drug Application (NDA): 076744

NDA 076744 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 sixty-nine drug master file entries for this compound. Additional details are available on the testosterone propionate profile page.

Summary for 076744

Tradename:	TESTOSTERONE
Applicant:	Strides Pharma Intl
Ingredient:	testosterone
Patents:	0

Pharmacology for NDA: 076744

Mechanism of Action

Androgen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 076744

Androgens

Suppliers and Packaging for NDA: 076744

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TESTOSTERONE	testosterone	GEL;TRANSDERMAL	076744	ANDA	Strides Pharma Science Limited	64380-151	64380-151-02	30 DOSE PACK in 1 CARTON (64380-151-02) / 2.5 g in 1 DOSE PACK (64380-151-01)
TESTOSTERONE	testosterone	GEL;TRANSDERMAL	076744	ANDA	Strides Pharma Science Limited	64380-152	64380-152-02	30 DOSE PACK in 1 CARTON (64380-152-02) / 5 g in 1 DOSE PACK (64380-152-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TRANSDERMAL			Strength	25MG/2.5GM PACKET
Approval Date:	May 23, 2007	TE:	AB1	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TRANSDERMAL			Strength	50MG/5GM PACKET
Approval Date:	May 23, 2007	TE:	AB1	RLD:	No

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