Drug application
ETHINYL ESTRADIOL AND NORELGESTROMIN (ETHINYL ESTRADIOL, NORELGESTROMIN)
Drugs@FDA ANDA 213950 · AMNEAL
Key facts
| Drug name | ETHINYL ESTRADIOL AND NORELGESTROMIN |
|---|---|
| Active ingredients | ETHINYL ESTRADIOL, NORELGESTROMIN |
| Application type | ANDA |
| Application number | 213950 |
| Company | AMNEAL |
| Dosage forms | FILM, EXTENDED RELEASE, TRANSDERMAL |
| Strength | 0.035MG/24HR;0.15MG/24HR |
| Marketing status | Prescription |
| TE codes | AB |
| Reference listed drug | No |
| Latest submission status date | Feb 25, 2021 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
- No 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: