Orange Book product
DEXTROAMPHETAMINE SULFATE 10MG
Orange Book ANDA 040361 · BARR LABORATORIES INC · Prescription
Key facts
| Proprietary name | DEXTROAMPHETAMINE SULFATE |
|---|---|
| Active ingredients | DEXTROAMPHETAMINE SULFATE |
| Strength | 10MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA040361 |
| Applicant holder | BARR LABORATORIES INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AA |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Jan 31, 2001 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.