Orange Book product · Brand (NDA)
DIBENZYLINE
PHENOXYBENZAMINE HYDROCHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
PHENOXYBENZAMINE HYDROCHLORIDE
Strength
10MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 008708
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2023PHENOXYBENZAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 204551 · RISING
- 2023PHENOXYBENZAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 215600 · AUROBINDO PHARMA
- 2022PHENOXYBENZAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 215042 · NOVITIUM PHARMA
- 2020PHENOXYBENZAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 212568 · AMNEAL
- 2017PHENOXYBENZAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 204522 · PH HEALTH
- 2012PHENOXYBENZAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 201050 · HIKMA
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.
