Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Covington
McKinsey
Baxter
QuintilesIMS
Farmers Insurance
Merck
Healthtrust
AstraZeneca
Queensland Health

Generated: November 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 080911

« Back to Dashboard

NDA 080911 describes TESTOPEL, which is a drug marketed by Auxilium Pharms Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the TESTOPEL profile page.

The generic ingredient in TESTOPEL is testosterone. There are sixty-seven drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the testosterone profile page.
Summary for 080911
Tradename:TESTOPEL
Applicant:Auxilium Pharms Inc
Ingredient:testosterone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 080911
Ingredient-typeAndrostanes
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 080911
Suppliers and Packaging for NDA: 080911
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TESTOPEL testosterone PELLET;IMPLANTATION 080911 ANDA Slate Pharma 43773-1001 43773-1001-2 10 AMPULE in 1 BOX (43773-1001-2) > 1 PELLET in 1 AMPULE
TESTOPEL testosterone PELLET;IMPLANTATION 080911 ANDA Slate Pharma 43773-1001 43773-1001-3 100 AMPULE in 1 BOX (43773-1001-3) > 1 PELLET in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:PELLET;IMPLANTATIONStrength75MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD: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:

UBS
Fish and Richardson
Julphar
Daiichi Sankyo
AstraZeneca
Fuji
Teva
US Army
Covington

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.