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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 202763

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NDA 202763 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 202763

Tradename:	TESTOSTERONE
Applicant:	Ani Pharms
Ingredient:	testosterone
Patents:	0

Medical Subject Heading (MeSH) Categories for 202763

Androgens

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GEL;TRANSDERMAL			Strength	25MG/2.5GM PACKET
Approval Date:	Feb 14, 2012	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GEL;TRANSDERMAL			Strength	50MG/5GM PACKET
Approval Date:	Feb 14, 2012	TE:		RLD:	No

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