Orange Book product
DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG
Orange Book ANDA 202594 · XIROMED LLC · Prescription
Key facts
| Proprietary name | DROSPIRENONE AND ETHINYL ESTRADIOL |
|---|---|
| Active ingredients | DROSPIRENONE, ETHINYL ESTRADIOL |
| Strength | 3MG;0.02MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA202594 |
| Applicant holder | XIROMED LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Oct 22, 2015 |
At a glance
- 10–99 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.