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Generated: November 20, 2018

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Details for New Drug Application (NDA): 208564

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NDA 208564 describes IMVEXXY, which is a drug marketed by Therapeuticsmd Inc and is included in one NDA. It is available from one supplier. There are two 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-six suppliers are listed for this compound. Additional details are available on the estradiol profile page.
Summary for 208564
Tradename:IMVEXXY
Applicant:Therapeuticsmd Inc
Ingredient:estradiol
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 208564
Ingredient-typeEstradiol Congeners
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 TherapeuticsMD, Inc. 50261-104 50261-104-08 1 BLISTER PACK in 1 CARTON (50261-104-08) > 8 INSERT in 1 BLISTER PACK
IMVEXXY estradiol INSERT;VAGINAL 208564 NDA TherapeuticsMD, Inc. 50261-104 50261-104-18 1 BLISTER PACK in 1 CARTON (50261-104-18) > 18 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
Regulatory Exclusivity Expiration:May 29, 2021
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Sign UpPatent Expiration:Dec 20, 2033Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Patent:➤ Sign UpPatent Expiration:Dec 20, 2033Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF DYSPAREUNIA

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