Drug application
PALIPERIDONE PALMITATE (PALIPERIDONE PALMITATE)
Drugs@FDA ANDA 212290 · MYLAN PHARMS INC
Key facts
| Drug name | PALIPERIDONE PALMITATE |
|---|---|
| Active ingredients | PALIPERIDONE PALMITATE |
| Application type | ANDA |
| Application number | 212290 |
| Company | MYLAN PHARMS INC |
| Dosage forms | INJECTABLE, SUSPENSION, EXTENDED RELEASE |
| Strength | 546MG/1.75ML |
| Marketing status | None (Tentative Approval) |
| Reference listed drug | No |
| Latest submission status date | May 20, 2024 |
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: