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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 208564


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NDA 208564 describes IMVEXXY, which is a drug marketed by Mayne Pharma and is included in one NDA. It is available from two suppliers. There are twenty patents protecting this drug. Additional details are available on the IMVEXXY profile page.

The generic ingredient in IMVEXXY is estradiol. There are seventy-five drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the estradiol profile page.
Summary for 208564
Tradename:IMVEXXY
Applicant:Mayne Pharma
Ingredient:estradiol
Patents:20
Pharmacology for NDA: 208564
Mechanism of ActionEstrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 208564
Suppliers and Packaging for NDA: 208564
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMVEXXY estradiol INSERT;VAGINAL 208564 NDA Mayne Pharma LLC 50261-104 50261-104-02 1 BLISTER PACK in 1 CARTON (50261-104-02) / 2 INSERT in 1 BLISTER PACK
IMVEXXY estradiol INSERT;VAGINAL 208564 NDA Mayne Pharma LLC 50261-104 50261-104-08 1 BLISTER PACK in 1 CARTON (50261-104-08) / 8 INSERT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INSERT;VAGINALStrength0.004MG
Approval Date:May 29, 2018TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Dec 20, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Patent:⤷  Sign UpPatent Expiration:Dec 20, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF DYSPAREUNIA
Patent:⤷  Sign UpPatent Expiration:Dec 20, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY

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