Details for New Drug Application (NDA): 208620

NDA 208620 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 208620

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

Pharmacology for NDA: 208620

Mechanism of Action

Androgen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 208620

Androgens

Suppliers and Packaging for NDA: 208620

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TESTOSTERONE	testosterone	GEL, METERED;TRANSDERMAL	208620	ANDA	Encube Ethicals Private Limited	21922-030	21922-030-20	1 BOTTLE, PUMP in 1 CARTON (21922-030-20) / 88 g in 1 BOTTLE, PUMP
TESTOSTERONE	testosterone	GEL, METERED;TRANSDERMAL	208620	ANDA	Dr. Reddy's Laboratories, Inc.	43598-304	43598-304-88	1 BOTTLE, PUMP in 1 CARTON (43598-304-88) / 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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