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Last Updated: July 2, 2020

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Details for New Drug Application (NDA): 203454


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NDA 203454 describes GRANISETRON HYDROCHLORIDE, which is a drug marketed by Akorn Inc, Am Regent, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Bionpharma Inc, Cipla Ltd, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Mylan Asi, Mylan Labs Ltd, Sandoz Inc, Teva Pharms Usa, West-ward Pharms Int, Wockhardt Usa, Yung Shin Pharm, Apotex Inc, Barr, Chartwell Molecular, Dr Reddys Labs Ltd, Epic Pharma Llc, Hikma, Mylan, Natco Pharma, Orchid Hlthcare, Taro, and Teva Pharms, and is included in forty-five NDAs. It is available from twelve suppliers. Additional details are available on the GRANISETRON HYDROCHLORIDE profile page.

The generic ingredient in GRANISETRON HYDROCHLORIDE is granisetron hydrochloride. There are twenty-six drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.
Summary for 203454
Tradename:GRANISETRON HYDROCHLORIDE
Applicant:Mylan Labs Ltd
Ingredient:granisetron hydrochloride
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
Approval Date:Apr 4, 2017TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 1MG BASE/ML (EQ 1MG BASE/ML)
Approval Date:Apr 4, 2017TE:RLD:No

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