Last Updated: November 8, 2026

Details for New Drug Application (NDA): 086419

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NDA 086419 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, Bpi Labs, 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 sixty 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 six drug master file entries for this compound. Additional details are available on the testosterone propionate profile page.

Summary for 086419

Tradename:	TESTOSTERONE
Applicant:	Watson Labs
Ingredient:	testosterone
Patents:	0

Medical Subject Heading (MeSH) Categories for 086419

Androgens

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	50MG/ML
Approval Date:	Aug 23, 1983	TE:		RLD:	No

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