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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School
US Army
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Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 083976

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NDA 083976 describes TESTRED, which is a drug marketed by Valeant Pharm Intl and is included in one NDA. It is available from one supplier. Additional details are available on the TESTRED profile page.

The generic ingredient in TESTRED 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 083976
Applicant:Valeant Pharm Intl
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 083976
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 083976
Suppliers and Packaging for NDA: 083976
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TESTRED methyltestosterone CAPSULE;ORAL 083976 ANDA Valeant Pharmaceuticals North America LLC 0187-0901 0187-0901-01 1 BOTTLE in 1 CARTON (0187-0901-01) > 100 CAPSULE in 1 BOTTLE
TESTRED methyltestosterone CAPSULE;ORAL 083976 ANDA Valeant Pharmaceuticals North America LLC 0187-0902 0187-0902-01 1 BOTTLE, GLASS in 1 CARTON (0187-0902-01) > 100 CAPSULE in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Federal Trade Commission
Boehringer Ingelheim

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