Drug application
PRONESTYL (PROCAINAMIDE HYDROCHLORIDE)
Drugs@FDA NDA 007335 · APOTHECON
Key facts
| Drug name | PRONESTYL |
|---|---|
| Active ingredients | PROCAINAMIDE HYDROCHLORIDE |
| Application type | NDA |
| Application number | 007335 |
| Company | APOTHECON |
| Dosage forms | CAPSULE, ORAL |
| Strength | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
| Marketing status | Discontinued |
| Reference listed drug | Yes |
| Latest submission class | Type 1 - New Molecular Entity |
| Latest submission status date | Jun 2, 1950 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
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.