FDA Orange Book · active-ingredient family
Amphetamine adipate; amphetamine sulfate; dextroamphetamine adipate; dextroamphetamine sulfate
Amphetamine adipate; amphetamine sulfate; dextroamphetamine adipate; dextroamphetamine sulfate is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
0
Brand (NDA)
2
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DELCOBESE×4 | TEVA | ANDA 083564 | — | Approved Prior to Jan 1, 1982 | |
| DELCOBESE×4 | TEVA | ANDA 083563 | — | Approved Prior to Jan 1, 1982 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Amphetamine adipate; amphetamine sulfate; dextroamphetamine adipate; dextroamphetamine sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
