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Last Updated: January 27, 2020

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Details for New Drug Application (NDA): 204571

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NDA 204571 describes TESTOSTERONE, which is a drug marketed by Actavis Labs Ut Inc, Amneal Pharms Llc, Dr Reddys, Lupin Atlantis, Perrigo Israel, Twi Pharms, Ani Pharms Inc, Par Pharm, Perrigo Uk Finco, Watson Labs, Cipla, Lupin Ltd, Am Regent, Hikma Farmaceutica, Mylan Institutional, Paddock Llc, Sandoz Inc, Sun Pharm Inds Ltd, Watson Pharms Inc, West-ward Pharms Int, Wilshire Pharms Inc, Nexus Pharms, Bel Mar, Elkins Sinn, and Lilly, and is included in forty-nine NDAs. It is available from nine 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 204571
Applicant:Actavis Labs Ut Inc
Formulation / Manufacturing:see details
Pharmacology for NDA: 204571
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 204571
Suppliers and Packaging for NDA: 204571
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TESTOSTERONE testosterone GEL, METERED;TRANSDERMAL 204571 ANDA Actavis Pharma, Inc. 0591-2363 0591-2363-60 1 CANISTER in 1 CARTON (0591-2363-60) > 60 g in 1 CANISTER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL, METERED;TRANSDERMALStrength10MG/0.5GM ACTUATION
Approval Date:Aug 5, 2015TE:ABRLD:No

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