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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
US Army
Cantor Fitzgerald

Generated: March 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203098

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NDA 203098 describes TESTOSTERONE, which is a drug marketed by Actavis Labs Ut Inc, Perrigo Israel, Ani Pharms Inc, Par Pharm, Perrigo Uk Finco, Watson Labs, Cipla Ltd, Lupin Ltd, Hikma Farmaceutica, Luitpold Pharms Inc, Mylan Institutional, Paddock Llc, Sandoz Inc, Sun Pharm Inds Ltd, Watson Pharms Inc, West-ward Pharms Int, Bel Mar, Elkins Sinn, and Lilly, and is included in forty-two NDAs. It is available from four suppliers. Additional details are available on the TESTOSTERONE profile page.

The generic ingredient in TESTOSTERONE is testosterone propionate. There are sixty-three drug master file entries for this compound. Additional details are available on the testosterone propionate profile page.
Summary for 203098
Applicant:Perrigo Israel
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 203098
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 203098
Suppliers and Packaging for NDA: 203098
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TESTOSTERONE testosterone GEL, METERED;TRANSDERMAL 203098 NDA Perrigo New York Inc 45802-116 N 45802-116-02
TESTOSTERONE testosterone GEL, METERED;TRANSDERMAL 203098 NDA Perrigo New York Inc 45802-116 N 45802-116-39

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL, METERED;TRANSDERMALStrength12.5MG/1.25GM ACTUATION
Approval Date:Jan 31, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:GEL;TRANSDERMALStrength25MG/2.5GM PACKET
Approval Date:Jan 31, 2013TE:AB1RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:GEL;TRANSDERMALStrength50MG/5GM PACKET
Approval Date:Jan 31, 2013TE:AB1RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Queensland Health

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