Drugs@FDA: FDA-Approved Drugs

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

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

Showing 1 to 2 of 2 entries

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
09/09/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Showing 1 to 1 of 1 entries

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
09/08/2023	SUPPL-17	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.
05/26/2022	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
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.

Showing 1 to 4 of 4 entries

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

CSV Excel Print

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	LEGACY PHARMA

Showing 1 to 4 of 4 entries

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

CSV Excel Print

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	LEGACY PHARMA

Showing 1 to 4 of 4 entries