➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim
Colorcon
Moodys
Express Scripts
AstraZeneca

Last Updated: August 2, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204255


Email this page to a colleague

« Back to Dashboard

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
Tradename:TESTOSTERONE
Applicant:Perrigo Israel
Ingredient:testosterone
Patents:0
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

Active Rx/OTC/Discontinued:RXDosage:SOLUTION, METERED;TRANSDERMALStrength30MG/1.5ML ACTUATION
Approval Date:Feb 28, 2017TE:ATRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
McKesson
McKinsey
Medtronic
Express Scripts
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.