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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 218718


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NDA 218718 describes FEMLYV, which is a drug marketed by Millicent Pr and is included in one NDA. It is available from one supplier. Additional details are available on the FEMLYV profile page.

The generic ingredient in FEMLYV is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 218718
Tradename:FEMLYV
Applicant:Millicent Pr
Ingredient:ethinyl estradiol; norethindrone acetate
Patents:0
Suppliers and Packaging for NDA: 218718
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FEMLYV ethinyl estradiol; norethindrone acetate TABLET, ORALLY DISINTEGRATING;ORAL 218718 NDA Millicent US, Inc. 72495-601 72495-601-28 1 POUCH in 1 CARTON (72495-601-28) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
FEMLYV ethinyl estradiol; norethindrone acetate TABLET, ORALLY DISINTEGRATING;ORAL 218718 NDA Millicent US, Inc. 72495-601 72495-601-84 3 POUCH in 1 CARTON (72495-601-84) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength0.02MG;1MG
Approval Date:Jul 22, 2024TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 22, 2027
Regulatory Exclusivity Use:NEW PRODUCT

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