Drug application
ORTHO-NOVUM 10/11-21 (ETHINYL ESTRADIOL, NORETHINDRONE)
Drugs@FDA NDA 018354 · ORTHO MCNEIL JANSSEN
Key facts
| Drug name | ORTHO-NOVUM 10/11-21 |
|---|---|
| Active ingredients | ETHINYL ESTRADIOL, NORETHINDRONE |
| Application type | NDA |
| Application number | 018354 |
| Company | ORTHO MCNEIL JANSSEN |
| Dosage forms | 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| Strength | 0.035MG,0.035MG;0.5MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
| Marketing status | Discontinued |
| Reference listed drug | Yes |
| Latest submission class | Type 3 - New Dosage Form |
| Latest submission status date | Jan 11, 1982 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.