FDA Orange Book · active-ingredient family
Dextroamphetamine
Dextroamphetamine is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:XELSTRYM · NDA 215401
1
Brand (NDA)
0
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · system
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| XELSTRYMRLD×4 | NOVEN PHARMS INC | NDA 215401 | — | Mar 22, 2022 |
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9456993 | Oct 24, 2033 | in 7 yr 5 mo | ProductU-3340 |
| 9474722 | Oct 24, 2033 | in 7 yr 5 mo | Product |
| 11559501 | Jan 06, 2042 | in 15 yr 9 mo | Product |
Dextroamphetamine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
