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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091137

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NDA 091137 describes GRANISETRON HYDROCHLORIDE, which is a drug marketed by Akorn Inc, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Bionpharma Inc, Cipla Ltd, Fresenius Kabi Usa, Hikma Farmaceutica, Luitpold, Mylan Asi, Mylan Labs Ltd, Sandoz Inc, Teva Pharms Usa, West-ward Pharms Int, Wockhardt Usa, Apotex Inc, Barr, Chartwell Molecular, Dr Reddys Labs Ltd, Epic Pharma Llc, Mylan, Natco Pharma, Orchid Hlthcare, Taro Pharm, and Teva Pharms, and is included in forty-four NDAs. It is available from seventeen 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. Seventeen suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.
Summary for 091137
Tradename:GRANISETRON HYDROCHLORIDE
Applicant:Mylan Asi
Ingredient:granisetron hydrochloride
Patents:0
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details
Pharmacology for NDA: 091137
Suppliers and Packaging for NDA: 091137
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 091137 ANDA Sagent Pharmaceuticals 25021-781 N 25021-781-04
GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 091137 ANDA Mylan Institutional LLC 67457-864 N 67457-864-04

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 4MG BASE/4ML (EQ 1MG BASE/ML)
Approval Date:Apr 9, 2010TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
QuintilesIMS
Johnson and Johnson
Harvard Business School
Deloitte
Covington
McKinsey
AstraZeneca
McKesson

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