Details for New Drug Application (NDA): 218718
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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: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 0.02MG;1MG | ||||
Approval Date: | Jul 22, 2024 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Jul 22, 2027 | ||||||||
Regulatory Exclusivity Use: | NEW PRODUCT |
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