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Approved Drug Products containing Alosetron Hydrochloride listed in the FDA Orange Book. Original Data : FDA Website

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01 2AMNEAL PHARMS

02 2ENDO OPERATIONS

03 2EYWA PHARMA

04 2HIKMA

05 2MANKIND PHARMA

06 2RISING PHARMA

07 2SEBELA IRELAND LTD

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01

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ALOSETRON HYDROCHLORIDE

Brand Name : ALOSETRON HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 0.5MG BASE

Approval Date : 2016-12-22

Application Number : 206647

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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02

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ALOSETRON HYDROCHLORIDE

Brand Name : ALOSETRON HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1MG BASE

Approval Date : 2016-12-22

Application Number : 206647

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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03

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ALOSETRON HYDROCHLORIDE

Brand Name : ALOSETRON HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 0.5MG BASE

Approval Date : 2015-05-04

Application Number : 200652

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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04

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ALOSETRON HYDROCHLORIDE

Brand Name : ALOSETRON HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1MG BASE

Approval Date : 2015-05-04

Application Number : 200652

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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05

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ALOSETRON HYDROCHLORIDE

Brand Name : LOTRONEX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1MG BASE

Approval Date : 2000-02-09

Application Number : 21107

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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06

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ALOSETRON HYDROCHLORIDE

Brand Name : LOTRONEX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 0.5MG BASE

Approval Date : 2003-12-23

Application Number : 21107

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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07

ENDO OPERATIONS

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ALOSETRON HYDROCHLORIDE

Brand Name : ALOSETRON HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 0.5MG BASE

Approval Date : 2018-02-23

Application Number : 206113

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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08

ENDO OPERATIONS

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ENDO OPERATIONS

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ALOSETRON HYDROCHLORIDE

Brand Name : ALOSETRON HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1MG BASE

Approval Date : 2018-02-23

Application Number : 206113

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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09

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ALOSETRON HYDROCHLORIDE

Brand Name : ALOSETRON HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 0.5MG BASE

Approval Date : 2019-01-14

Application Number : 209180

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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ALOSETRON HYDROCHLORIDE

Brand Name : ALOSETRON HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1MG BASE

Approval Date : 2019-01-14

Application Number : 209180

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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