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Last Updated: July 14, 2020

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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 one supplier. Additional details are available on the TESTOPEL profile page.

The generic ingredient in TESTOPEL is testosterone. There are sixty-nine drug master file entries for this compound. Nineteen 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
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 Endo Pharmaceuticals Inc. 66887-004 66887-004-10 10 AMPULE in 1 BOX (66887-004-10) > 1 PELLET in 1 AMPULE (66887-004-01)
TESTOPEL testosterone PELLET;IMPLANTATION 080911 ANDA Endo Pharmaceuticals Inc. 66887-004 66887-004-20 100 AMPULE in 1 BOX (66887-004-20) > 1 PELLET in 1 AMPULE (66887-004-01)

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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Serving leading biopharmaceutical companies globally:

Express Scripts
McKesson
McKinsey
Medtronic
Mallinckrodt
Dow

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