FDA Orange Book · active-ingredient family
Amoxapine
Amoxapine is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ASENDIN · NDA 018021
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ASENDIN×4 | LEDERLE | NDA 018021 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AMOXAPINE×4 | WATSON LABS | ANDA 072691 | AB | Aug 28, 1992 | |
| AMOXAPINE×4 | CHARTWELL RX | ANDA 072879 | AB | Jun 28, 1991 | |
| AMOXAPINE | WATSON PHARMS TEVA | ANDA 072418 | — | Aug 01, 1989 | |
| AMOXAPINE | WATSON PHARMS TEVA | ANDA 072419 | — | Aug 01, 1989 | |
| AMOXAPINE | WATSON PHARMS TEVA | ANDA 072420 | — | May 11, 1989 | |
| AMOXAPINE | WATSON PHARMS TEVA | ANDA 072421 | — | May 11, 1989 |
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.
Amoxapine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
