Drug application
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE and 1 more)
Drugs@FDA ANDA 205401 · ANI PHARMS
Key facts
| Drug name | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE |
|---|---|
| Active ingredients | AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE |
| Application type | ANDA |
| Application number | 205401 |
| Company | ANI PHARMS |
| Dosage forms | CAPSULE, EXTENDED RELEASE, ORAL |
| Strength | 1.25MG;1.25MG;1.25MG;1.25MG |
| Marketing status | Prescription |
| TE codes | AB1 |
| Reference listed drug | No |
| Latest submission status date | Jan 22, 2019 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- 10–99 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.