Drug application
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE and 1 more)
Drugs@FDA ANDA 206304 · COREPHARMA
Key facts
| Drug name | DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE |
|---|---|
| Active ingredients | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE |
| Application type | ANDA |
| Application number | 206304 |
| Company | COREPHARMA |
| Dosage forms | CAPSULE, EXTENDED RELEASE, ORAL |
| Strength | 5MG |
| Marketing status | None (Tentative Approval) |
| Reference listed drug | No |
| Latest submission status date | Apr 15, 2016 |
At a glance
- 1–9 Submissions
- 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.