Details for New Drug Application (NDA): 205488
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NDA 205488 describes NATESTO, which is a drug marketed by Acerus and is included in one NDA. It is available from one supplier. There are five 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. Twenty-one 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. Twenty-one suppliers are listed for this compound. Additional details are available on the testosterone profile page.
Summary for 205488
| Tradename: | NATESTO |
| Applicant: | Acerus |
| Ingredient: | testosterone |
| Patents: | 5 |
| 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 | Acerus Pharmaceuticals Corporation | 42667-5511 | 42667-5511-1 | 1 APPLICATOR in 1 BOX (42667-5511-1) / 11 g in 1 APPLICATOR |
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: | See Plans and Pricing | Patent Expiration: | Mar 17, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | NASAL ADMINISTRATION OF A TESTOSTERONE GEL TO A PATIENT TO TREAT THE PATIENT FOR A CONDITION ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE | ||||||||
| Patent: | See Plans and Pricing | Patent Expiration: | Feb 4, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | See Plans and Pricing | Patent Expiration: | Feb 4, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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