Drug application
OXCARBAZEPINE (OXCARBAZEPINE)
Drugs@FDA ANDA 078734 · SUN PHARM INDS LTD
Key facts
| Drug name | OXCARBAZEPINE |
|---|---|
| Active ingredients | OXCARBAZEPINE |
| Application type | ANDA |
| Application number | 078734 |
| Company | SUN PHARM INDS LTD |
| Dosage forms | SUSPENSION, ORAL |
| Strength | 300MG/5ML |
| Marketing status | Prescription |
| TE codes | AB |
| Reference listed drug | No |
| Latest submission status date | Jun 26, 2009 |
At a glance
- 1–9 Submissions
- 1–9 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: