Drug application
DEXEDRINE SPANSULE (DEXTROAMPHETAMINE SULFATE)
Drugs@FDA NDA 017078 · IMPAX LABS INC
Key facts
| Drug name | DEXEDRINE SPANSULE |
|---|---|
| Active ingredients | DEXTROAMPHETAMINE SULFATE |
| Application type | NDA |
| Application number | 017078 |
| Company | IMPAX LABS INC |
| Dosage forms | CAPSULE, EXTENDED RELEASE, ORAL |
| Strength | 5MG |
| Marketing status | Prescription |
| TE codes | AB |
| Reference listed drug | Yes |
| Latest submission class | Type 5 - New Formulation or New Manufacturer |
| Latest submission status date | Aug 2, 1976 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- 10–99 Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
- No 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: