Orange Book product
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL 0.05MG;1MG
Orange Book ANDA 204704 · XIROMED LLC · Prescription
Key facts
| Proprietary name | ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL |
|---|---|
| Active ingredients | ETHINYL ESTRADIOL, ETHYNODIOL DIACETATE |
| Strength | 0.05MG;1MG |
| Dosage form | TABLET |
| Route | ORAL-28 |
| Application | ANDA204704 |
| Applicant holder | XIROMED LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Feb 9, 2016 |
At a glance
- 1–9 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.