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Last Updated: January 23, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204570

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NDA 204570 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 204570
Tradename:TESTOSTERONE
Applicant:Actavis Labs Ut Inc
Ingredient:testosterone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204570
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 204570
Suppliers and Packaging for NDA: 204570
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TESTOSTERONE testosterone GEL, METERED;TRANSDERMAL 204570 ANDA Actavis Pharma, Inc. 0591-2924 0591-2924-18 1 BOTTLE, PUMP in 1 CARTON (0591-2924-18) > 88 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL, METERED;TRANSDERMALStrength1.62% (20.25MG/1.25GM ACTUATION)
Approval Date:Apr 10, 2019TE:ABRLD:No

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