FDA Orange Book · active-ingredient family
Phenoxybenzamine hydrochloride
Phenoxybenzamine hydrochloride 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:DIBENZYLINE · NDA 008708
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DIBENZYLINERLD | ADVANZ PHARMA | NDA 008708 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PHENOXYBENZAMINE HYDROCHLORIDE | RISING | ANDA 204551 | AB | Jun 20, 2023 | |
| PHENOXYBENZAMINE HYDROCHLORIDE | AUROBINDO PHARMA | ANDA 215600 | AB | May 08, 2023 | |
| PHENOXYBENZAMINE HYDROCHLORIDE | NOVITIUM PHARMA | ANDA 215042 | AB | Jul 19, 2022 | |
| PHENOXYBENZAMINE HYDROCHLORIDE | AMNEAL | ANDA 212568 | AB | Oct 27, 2020 | |
| PHENOXYBENZAMINE HYDROCHLORIDE | PH HEALTH | ANDA 204522 | AB | Jan 24, 2017 | |
| PHENOXYBENZAMINE HYDROCHLORIDE | HIKMA | ANDA 201050 | — | Jul 16, 2012 |
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.
Phenoxybenzamine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
