Details for New Drug Application (NDA): 018354
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NDA 018354 describes ORTHO-NOVUM 10/11-28, which is a drug marketed by Ortho Mcneil Janssen and is included in one NDA. Additional details are available on the ORTHO-NOVUM 10/11-28 profile page.
The generic ingredient in ORTHO-NOVUM 10/11-28 is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
The generic ingredient in ORTHO-NOVUM 10/11-28 is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
Summary for 018354
| Tradename: | ORTHO-NOVUM 10/11-28 |
| Applicant: | Ortho Mcneil Janssen |
| Ingredient: | ethinyl estradiol; norethindrone |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-21 | Strength | 0.035MG,0.035MG;0.5MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jan 11, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-28 | Strength | 0.035MG,0.035MG;0.5MG,1MG | ||||
| Approval Date: | Jan 11, 1982 | TE: | RLD: | Yes | |||||
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