Details for New Drug Application (NDA): 208564
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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 Action | Estrogen 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: | RX | Dosage: | INSERT;VAGINAL | Strength | 0.004MG | ||||
Approval Date: | May 29, 2018 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 20, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 20, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF DYSPAREUNIA | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 20, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY |
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