Drug application
LEUPROLIDE ACETATE (LEUPROLIDE ACETATE)
Drugs@FDA ANDA 213829 · SOMERSET THERAPS LLC
Key facts
| Drug name | LEUPROLIDE ACETATE |
|---|---|
| Active ingredients | LEUPROLIDE ACETATE |
| Application type | ANDA |
| Application number | 213829 |
| Company | SOMERSET THERAPS LLC |
| Dosage forms | SOLUTION, SUBCUTANEOUS |
| Strength | 14MG/2.8ML (1MG/0.2ML) |
| Marketing status | Prescription |
| TE codes | AP |
| Reference listed drug | No |
| Latest submission status date | Aug 13, 2021 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
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.