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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213614
Company: MANKIND PHARMA

Products on ANDA 213614

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 213614

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/09/2020	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-17	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213614s017ltr.pdf
05/05/2022	SUPPL-13	REMS - MODIFIED - D-N-A		Label is not available on this site.
10/18/2021	SUPPL-10	REMS - MODIFIED - D-N-A		Label is not available on this site.
05/26/2022	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 213614

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

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