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Last Updated: November 14, 2025

Details for New Drug Application (NDA): 208061

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NDA 208061 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, 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 208061

Tradename:	TESTOSTERONE
Applicant:	Lupin Ltd
Ingredient:	testosterone
Patents:	0

Pharmacology for NDA: 208061

Mechanism of Action	Androgen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 208061

Androgens

Suppliers and Packaging for NDA: 208061

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TESTOSTERONE	testosterone	SOLUTION, METERED;TRANSDERMAL	208061	ANDA	Lupin Pharmaceuticals, Inc.	68180-943	68180-943-11	1 BOTTLE, WITH APPLICATOR in 1 CARTON (68180-943-11) / 90 mL in 1 BOTTLE, WITH APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION, METERED;TRANSDERMAL			Strength	30MG/1.5ML ACTUATION
Approval Date:	Oct 23, 2017	TE:	AT	RLD:	No

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