Orange Book product
ESTRADIOL VALERATE 40MG/ML
Orange Book ANDA 216656 · XIROMED PHARMA ESPANA SL · Prescription
Key facts
| Proprietary name | ESTRADIOL VALERATE |
|---|---|
| Active ingredients | ESTRADIOL VALERATE |
| Strength | 40MG/ML |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | ANDA216656 |
| Applicant holder | XIROMED PHARMA ESPANA SL |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AO |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Apr 28, 2023 |
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.