FDA Orange Book · active-ingredient family
Amphetamine resin complex; dextroamphetamine resin complex
Amphetamine resin complex; dextroamphetamine resin complex is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:BIPHETAMINE 12.5 · NDA 010093
1
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BIPHETAMINE 12.5×3 | UCB INC | NDA 010093 | — | 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 resin complex; dextroamphetamine resin complex — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
