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Generated: December 10, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076744

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NDA 076744 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 076744

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: 076744

Ingredient-typeAndrostanes
Mechanism of ActionAndrogen Receptor Agonists

Suppliers and Packaging for NDA: 076744

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TESTOSTERONE testosterone GEL;TRANSDERMAL 076744 ANDA Par Pharmaceutical, Inc. 49884-418 49884-418-72 30 PACKET in 1 CARTON (49884-418-72) > 2.5 g in 1 PACKET (49884-418-48)
TESTOSTERONE testosterone GEL;TRANSDERMAL 076744 ANDA Par Pharmaceutical, Inc. 49884-510 49884-510-72 30 PACKET in 1 CARTON (49884-510-72) > 5 g in 1 PACKET (49884-510-63)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TRANSDERMALStrength25MG/2.5GM PACKET
Approval Date:May 23, 2007TE:AB1RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:GEL;TRANSDERMALStrength50MG/5GM PACKET
Approval Date:May 23, 2007TE:AB1RLD:No


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