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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Cipla
Dow
US Army
Daiichi Sankyo
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Mallinckrodt
Harvard Business School
Citi
Federal Trade Commission
Julphar

Generated: December 13, 2017

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-two 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:1
Applicant:1
Ingredient:1
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 43773-1001-3 100 AMPULE in 1 BOX (43773-1001-3) > 1 PELLET in 1 AMPULE
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

Summary 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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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Citi
Merck
Dow
Cipla
Fuji
Federal Trade Commission
Teva
Daiichi Sankyo
Moodys

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.

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