Details for New Drug Application (NDA): 012728
✉ Email this page to a colleague
The generic ingredient in ORTHO-NOVUM 2-21 is mestranol; norethindrone. There are eleven drug master file entries for this compound. Additional details are available on the mestranol; norethindrone profile page.
Summary for 012728
Tradename: | ORTHO-NOVUM 2-21 |
Applicant: | Ortho Mcneil Pharm |
Ingredient: | mestranol; norethindrone |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-21 | Strength | 0.06MG;10MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No |
Profile for product number 004
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-21 | Strength | 0.05MG;1MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No |
Profile for product number 005
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-21 | Strength | 0.1MG;2MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No |
Complete Access Available with Subscription