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-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
The generic ingredient in FEMLYV is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-seven 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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