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Julphar
Deloitte
Chinese Patent Office
McKesson
Cerilliant
Baxter
Farmers Insurance
Covington
Express Scripts
Merck

Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 080911

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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-three 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
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
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 E 43773-1001-2
TESTOPEL testosterone PELLET;IMPLANTATION 080911 ANDA Slate Pharma 43773-1001 E 43773-1001-3

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:PELLET;IMPLANTATIONStrength75MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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US Department of Justice
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Johnson and Johnson
Moodys
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Dow
Daiichi Sankyo
Cantor Fitzgerald

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