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 one supplier. 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-five suppliers are listed for this compound. Additional details are available on the estradiol profile page.
The generic ingredient in IMVEXXY is estradiol. There are seventy-five drug master file entries for this compound. Forty-five 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 |
| Formulation / Manufacturing: | see details |
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: | ⤷ Try a Trial | Patent Expiration: | Dec 20, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Dec 20, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF DYSPAREUNIA | ||||||||
| Patent: | ⤷ Try a Trial | 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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