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Last Updated: August 2, 2021

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Details for New Drug Application (NDA): 204255

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NDA 204255 describes TESTOSTERONE, which is a drug marketed by Actavis Labs Ut Inc, Aleor Dermaceuticals, Amneal, Dr Reddys, Lupin, Perrigo Israel, Twi Pharms, Xiromed, Ani Pharms, Par Pharm, Perrigo Uk Finco, Watson Labs, Apotex, Cipla, Dash Pharms, 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 fifty-three 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 204255
Applicant:Perrigo Israel
Formulation / Manufacturing:see details
Pharmacology for NDA: 204255
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 204255
Suppliers and Packaging for NDA: 204255
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TESTOSTERONE testosterone SOLUTION, METERED;TRANSDERMAL 204255 ANDA Perrigo New York Inc 45802-610 45802-610-01 1 BOTTLE, PUMP in 1 CARTON (45802-610-01) > 110 mL in 1 BOTTLE, PUMP

Profile for product number 001

Approval Date:Feb 28, 2017TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
Boehringer Ingelheim

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