Orange Book product
ADDERALL XR 10 2.5MG;2.5MG;2.5MG;2.5MG
Orange Book NDA 021303 · TAKEDA PHARMACEUTICALS USA INC · Prescription
Key facts
| Proprietary name | ADDERALL XR 10 |
|---|---|
| Active ingredients | AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE |
| Strength | 2.5MG;2.5MG;2.5MG;2.5MG |
| Dosage form | CAPSULE, EXTENDED RELEASE |
| Route | ORAL |
| Application | NDA021303 |
| Applicant holder | TAKEDA PHARMACEUTICALS USA INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB1 |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | No |
| Approval date | Oct 11, 2001 |
At a glance
- 10–99 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- Yes 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.