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ALOSETRON HYDROCHLORIDE

ANDA

ALOSETRON HYDROCHLORIDE | A206647 | AMNEAL PHARMACEUTICALS OF NEW YORK LLC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: LOTRONEX(TE code: AB)

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 -16	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: Dec 22, 2016

No patent or exclusivity listings for this strength.

#002 — EQ 1MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 22, 2016