Drug application
HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
Drugs@FDA ANDA 075440 · MYLAN LABS LTD
Key facts
| Drug name | HALOPERIDOL DECANOATE |
|---|---|
| Active ingredients | HALOPERIDOL DECANOATE |
| Application type | ANDA |
| Application number | 075440 |
| Company | MYLAN LABS LTD |
| Dosage forms | INJECTABLE, INJECTION |
| Strength | EQ 50MG BASE/ML |
| Marketing status | Prescription |
| TE codes | AO |
| Reference listed drug | No |
| Latest submission status date | Feb 28, 2000 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- None Label versions
- 1–9 Products
- 10–99 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: