Drug application
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (ETHINYL ESTRADIOL, NORETHINDRONE)
Drugs@FDA NDA 022573 · TEVA BRANDED PHARM
Key facts
| Drug name | NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE |
|---|---|
| Active ingredients | ETHINYL ESTRADIOL, NORETHINDRONE |
| Application type | NDA |
| Application number | 022573 |
| Company | TEVA BRANDED PHARM |
| Dosage forms | TABLET, CHEWABLE, ORAL |
| Strength | 0.025MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
| Marketing status | Discontinued |
| TE codes | AB |
| Reference listed drug | Yes |
| Latest submission class | Type 5 - New Formulation or New Manufacturer |
| Latest submission status date | Dec 22, 2010 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- 1–9 Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
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.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: