Drug application
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL (ETHINYL ESTRADIOL, NORETHINDRONE ACETATE)
Drugs@FDA ANDA 076629 · DR REDDYS LABS SA
Key facts
| Drug name | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL |
|---|---|
| Active ingredients | ETHINYL ESTRADIOL, NORETHINDRONE ACETATE |
| Application type | ANDA |
| Application number | 076629 |
| Company | DR REDDYS LABS SA |
| Dosage forms | TABLET, ORAL-28 |
| Strength | 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG |
| Marketing status | Discontinued |
| Reference listed drug | No |
| Latest submission status date | Mar 18, 2010 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- No 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: