Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Deloitte
McKesson
Cipla
Medtronic
US Army
Boehringer Ingelheim
Daiichi Sankyo
QuintilesIMS

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204851

« Back to Dashboard

NDA 204851 describes METHYLTESTOSTERONE, which is a drug marketed by Heather, Impax Labs Inc, Impax Labs, Lilly, Purepac Pharm, Pvt Form, Tablicaps, Usl Pharma, Inwood Labs, Kv Pharm, Lannett, Parke Davis, Watson Labs, and West Ward, and is included in twenty-seven NDAs. It is available from one supplier. Additional details are available on the METHYLTESTOSTERONE profile page.

The generic ingredient in METHYLTESTOSTERONE is methyltestosterone. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the methyltestosterone profile page.
Summary for 204851
Tradename:METHYLTESTOSTERONE
Applicant:Impax Labs Inc
Ingredient:methyltestosterone
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 204851
Ingredient-typeAndrostanes
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 204851
Suppliers and Packaging for NDA: 204851
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLTESTOSTERONE methyltestosterone CAPSULE;ORAL 204851 ANDA Impax Generics 0115-1408 N 0115-1408-01
METHYLTESTOSTERONE methyltestosterone CAPSULE;ORAL 204851 ANDA Impax Generics 0115-1408 N 0115-1408-08

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Sep 21, 2015TE:ABRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Express Scripts
Cerilliant
Farmers Insurance
Baxter
AstraZeneca
Harvard Business School
Dow
Fuji

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 verifification 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.