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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 212301

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NDA 212301 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, 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 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 212301

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

Medical Subject Heading (MeSH) Categories for 212301

Androgens

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION, METERED;TRANSDERMAL			Strength	30MG/1.5ML ACTUATION
Approval Date:	Jan 11, 2021	TE:		RLD:	No

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