An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 209180
Company: RISING

Products on ANDA 209180

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALOSETRON HYDROCHLORIDE	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	AB	No	No
ALOSETRON HYDROCHLORIDE	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209180

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/14/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/08/2023	SUPPL-6	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209180s006ltr.pdf
05/05/2022	SUPPL-5	REMS - MODIFIED - D-N-A		Label is not available on this site.
10/18/2021	SUPPL-4	REMS - MODIFIED - D-N-A		Label is not available on this site.
11/06/2019	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209180

ALOSETRON HYDROCHLORIDE

TABLET;ORAL; EQ 0.5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALOSETRON HYDROCHLORIDE	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	206647	AMNEAL PHARMS
ALOSETRON HYDROCHLORIDE	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	211621	HIBROW HLTHCARE
ALOSETRON HYDROCHLORIDE	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	213614	MANKIND PHARMA
ALOSETRON HYDROCHLORIDE	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	209180	RISING
LOTRONEX	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	Yes	AB	021107	LEGACY PHARMA

TABLET;ORAL; EQ 1MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALOSETRON HYDROCHLORIDE	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	206647	AMNEAL PHARMS
ALOSETRON HYDROCHLORIDE	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	211621	HIBROW HLTHCARE
ALOSETRON HYDROCHLORIDE	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	213614	MANKIND PHARMA
ALOSETRON HYDROCHLORIDE	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	209180	RISING
LOTRONEX	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET;ORAL	Prescription	Yes	AB	021107	LEGACY PHARMA

Top