Details for New Drug Application (NDA): 203435
✉ Email this page to a colleague
NDA 203435 describes LERIBANE, which is a drug marketed by Novast Labs and is included in one NDA. Additional details are available on the LERIBANE profile page.
The generic ingredient in LERIBANE is ethinyl estradiol; norethindrone acetate. There is one drug master file entry for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
The generic ingredient in LERIBANE is ethinyl estradiol; norethindrone acetate. There is one drug master file entry for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 203435
| Tradename: | LERIBANE |
| Applicant: | Novast Labs |
| Ingredient: | ethinyl estradiol; norethindrone acetate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.005MG;1MG | ||||
| Approval Date: | Jun 3, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.0025MG;0.5MG | ||||
| Approval Date: | Jun 3, 2016 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
