Orange Book product
LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML)
Orange Book ANDA 215826 · ZYDUS PHARMACEUTICALS USA INC · Prescription
Key facts
| Proprietary name | LEUPROLIDE ACETATE |
|---|---|
| Active ingredients | LEUPROLIDE ACETATE |
| Strength | 14MG/2.8ML (1MG/0.2ML) |
| Dosage form | SOLUTION |
| Route | SUBCUTANEOUS |
| Application | ANDA215826 |
| Applicant holder | ZYDUS PHARMACEUTICALS USA INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Nov 13, 2025 |
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.