Drug application
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE and 1 more)
Drugs@FDA ANDA 211546 · SPECGX LLC
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 | 211546 |
| Company | SPECGX LLC |
| Dosage forms | CAPSULE, EXTENDED RELEASE, ORAL |
| Strength | 3.125MG;3.125MG;3.125MG;3.125MG |
| Marketing status | Prescription |
| TE codes | AB2 |
| Reference listed drug | No |
| Latest submission status date | Aug 31, 2023 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- 1–9 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.