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Generated: April 26, 2017

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Details for New Drug Application (NDA): 204571

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NDA 204571 describes TESTOSTERONE, which is a drug marketed by Watson Labs, Actavis Labs Ut Inc, Par Pharm, Perrigo Israel, Ani Pharms Inc, Sandoz Inc, Sun Pharm Inds Ltd, Paddock Llc, Watson Pharms Inc, Hikma Farmaceutica, Mylan Institutional, West-ward Pharms Int, Bel Mar, Lilly, and Elkins Sinn, and is included in thirty-six 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-one drug master file entries for this compound. Additional details are available on the testosterone propionate profile page.

Summary for NDA: 204571

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL, METERED;TRANSDERMALStrength10MG/0.5GM ACTUATION
Approval Date:Aug 5, 2015TE:ABRLD:No


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