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Generated: November 20, 2018

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Details for New Drug Application (NDA): 205488

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NDA 205488 describes NATESTO, which is a drug marketed by Aytu Bioscience Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the NATESTO profile page.

The generic ingredient in NATESTO is testosterone. There are sixty-seven drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the testosterone profile page.
Summary for 205488
Tradename:NATESTO
Applicant:Aytu Bioscience Inc
Ingredient:testosterone
Patents:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 205488
Ingredient-typeAndrostanes
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 205488
Suppliers and Packaging for NDA: 205488
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NATESTO testosterone GEL, METERED;NASAL 205488 NDA Aytu BioScience, Inc. 69654-239 69654-239-01 1 BOTTLE, PUMP in 1 CARTON (69654-239-01) > 60 GEL in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL, METERED;NASALStrength5.5MG/0.122GM ACTUATION
Approval Date:May 28, 2014TE:RLD:No
Patent:➤ Sign UpPatent Expiration:Feb 4, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Feb 4, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Feb 4, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:A METHOD OF TESTOSTERONE REPLACEMENT THERAPY COMPRISING THE STEP OF NASALLY ADMINISTERING TO A PATIENT IN NEED OF SUCH TREATMENT AN EFFECTIVE AMOUNT OF TESTOSTERONE GEL FORMULATION.

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