Orange Book product · Brand (NDA)
LOTRONEX
ALOSETRON HYDROCHLORIDE
At a glance
Dec 23, 2003
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 23, 2003
22 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
ALOSETRON HYDROCHLORIDE
Strength
EQ 0.5MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 021107
Product number
002
Marketing status
RX
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.
- 2020ALOSETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 213614 · MANKIND PHARMA
- 2019ALOSETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 211621 · HIBROW HLTHCARE
- 2019ALOSETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 209180 · RISING
- 2018ALOSETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 206113 · PH HEALTH
- 2016ALOSETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 206647 · AMNEAL PHARMS
- 2015ALOSETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 200652 · 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.
