Details for New Drug Application (NDA): 016715
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NDA 016715 describes ORTHO-NOVUM 1/80 28, which is a drug marketed by Ortho Mcneil Pharm and is included in one NDA. Additional details are available on the ORTHO-NOVUM 1/80 28 profile page.
The generic ingredient in ORTHO-NOVUM 1/80 28 is mestranol; norethindrone. There are eleven drug master file entries for this compound. Additional details are available on the mestranol; norethindrone profile page.
The generic ingredient in ORTHO-NOVUM 1/80 28 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 016715
| Tradename: | ORTHO-NOVUM 1/80 28 |
| Applicant: | Ortho Mcneil Pharm |
| Ingredient: | mestranol; norethindrone |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-21 | Strength | 0.08MG;1MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-28 | Strength | 0.08MG;1MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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