Drug application
METHYLNALTREXONE BROMIDE (METHYLNALTREXONE BROMIDE)
Drugs@FDA ANDA 216965 · GLAND PHARMA LTD
Key facts
| Drug name | METHYLNALTREXONE BROMIDE |
|---|---|
| Active ingredients | METHYLNALTREXONE BROMIDE |
| Application type | ANDA |
| Application number | 216965 |
| Company | GLAND PHARMA LTD |
| Dosage forms | INJECTABLE, INJECTION |
| Strength | 12MG/0.6ML |
| Marketing status | None (Tentative Approval) |
| Reference listed drug | No |
| Latest submission status date | Feb 5, 2025 |
At a glance
- 1–9 Submissions
- None Label versions
- None Products
- None Therapeutic equivalents
- Yes FDA letters on file
- No 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: