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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Medtronic
Harvard Business School
QuintilesIMS
Argus Health
McKesson
Cantor Fitzgerald
Chinese Patent Office
UBS
Express Scripts
Chubb

Generated: December 15, 2017

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, 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-one NDAs. It is available from three suppliers. Additional details are available on the TESTOSTERONE profile page.

The generic ingredient in TESTOSTERONE is testosterone propionate. There are sixty-two drug master file entries for this compound. Additional details are available on the testosterone propionate profile page.

Summary for 203098

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: 203098

Ingredient-typeAndrostanes
Mechanism of ActionAndrogen Receptor Agonists

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 45802-116-65 30 POUCH in 1 CARTON (45802-116-65) > 2.5 g in 1 POUCH
TESTOSTERONE testosterone GEL, METERED;TRANSDERMAL 203098 NDA Perrigo New York Inc 45802-116 45802-116-02 2 BOTTLE, PUMP in 1 CARTON (45802-116-02) > 88 g in 1 BOTTLE, PUMP

Summary for product number 001

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

Summary for product number 002

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

Summary 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 leading biopharmaceutical companies globally:

Cerilliant
Julphar
Healthtrust
Express Scripts
US Department of Justice
Cantor Fitzgerald
Boehringer Ingelheim
Citi
UBS
Argus Health

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