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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206647
Company: AMNEAL PHARMS

Products on ANDA 206647

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 206647

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/2016	ORIG-1	Approval		STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206647Orig1_Approval_Pkg.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/08/2023	SUPPL-16	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206647s016ltr.pdf
05/05/2022	SUPPL-12	REMS - MODIFIED - D-N-A		Label is not available on this site.
12/08/2023	SUPPL-11	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels		Label is not available on this site.
10/18/2021	SUPPL-9	REMS - MODIFIED - D-N-A		Label is not available on this site.
12/06/2019	SUPPL-4	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 206647

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	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	SEBELA IRELAND LTD

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	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	SEBELA IRELAND LTD

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