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ALOSETRON HYDROCHLORIDE

ANDA

ALOSETRON HYDROCHLORIDE | A206113 | PH HEALTH LTD

2 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Prometheus Laboratories Inc. v. Par Pharmaceutical Companies Inc. et al 1:2014cv01017 1 patentANDA 206113alosetron hydrochloride	D. Del.	2014-08-06	Terminated 2015-11-17	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain3 active DMFs

3 active API suppliers hold Drug Master Files for this ingredient.

CIPLA LTDALOSETRON HYDROCHLORIDE USP

DMF 221252009

NURAY CHEMICALS PVT LTDALOSETRON HYDROCHLORIDE

DMF 273782013

BIOPHORE INDIA PHARMACEUTICALS PVT LTDALOSETRON HYDROCHLORIDE

DMF 274702013

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 8, 2023	SUPPL -6	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 0.5MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 23, 2018

No patent or exclusivity listings for this strength.

#002 — EQ 1MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 23, 2018