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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 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-nine drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the testosterone profile page.
The generic ingredient in NATESTO is testosterone. There are sixty-nine drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the testosterone profile page.
Summary for 205488
| Tradename: | NATESTO |
| Applicant: | Aytu |
| Ingredient: | testosterone |
| Patents: | 4 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205488
| Mechanism of Action | Androgen 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: | RX | Dosage: | GEL, METERED;NASAL | Strength | 5.5MG/0.122GM ACTUATION | ||||
| Approval Date: | May 28, 2014 | TE: | RLD: | No | |||||
| Patent: | Start Trial | Patent Expiration: | Feb 4, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | Patent Expiration: | Feb 4, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | Patent Expiration: | Feb 4, 2024 | Product Flag? | Y | Substance 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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