Drug application
LEUPROLIDE ACETATE (LEUPROLIDE ACETATE)
Drugs@FDA ANDA 074728 · SANDOZ
Key facts
| Drug name | LEUPROLIDE ACETATE |
|---|---|
| Active ingredients | LEUPROLIDE ACETATE |
| Application type | ANDA |
| Application number | 074728 |
| Company | SANDOZ |
| 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 4, 1998 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- 1–9 Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
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.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: