Details for New Drug Application (NDA): 205488
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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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