Details for New Drug Application (NDA): 204213
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NDA 204213 describes FYAVOLV, which is a drug marketed by Lupin Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the FYAVOLV profile page.
The generic ingredient in FYAVOLV 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 FYAVOLV 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 204213
| Tradename: | FYAVOLV |
| Applicant: | Lupin Ltd |
| Ingredient: | ethinyl estradiol; norethindrone acetate |
| Patents: | 0 |
Pharmacology for NDA: 204213
| Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 204213
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FYAVOLV | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 204213 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-827 | 68180-827-09 | 90 TABLET, FILM COATED in 1 BOTTLE (68180-827-09) |
| FYAVOLV | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 204213 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-827 | 68180-827-73 | 3 POUCH in 1 CARTON (68180-827-73) / 1 BLISTER PACK in 1 POUCH / 28 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.0025MG;0.5MG | ||||
| Approval Date: | Dec 10, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.005MG;1MG | ||||
| Approval Date: | Dec 10, 2015 | TE: | AB | RLD: | No | ||||
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