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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
US Department of Justice
Julphar
Medtronic
Covington
Argus Health
Fuji
Dow
Cerilliant

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078564

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NDA 078564 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 078564
Tradename:GRANISETRON HYDROCHLORIDE
Applicant:Wockhardt Usa
Ingredient:granisetron hydrochloride
Patents:0
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details
Pharmacology for NDA: 078564
Suppliers and Packaging for NDA: 078564
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078564 ANDA WOCKHARDT LIMITED 55648-661 N 55648-661-01
GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078564 ANDA WOCKHARDT LIMITED 55648-661 N 55648-661-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1MG BASE/ML (EQ 1MG BASE/ML)
Approval Date:Jun 30, 2008TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Queensland Health
Cerilliant
US Army
Express Scripts
Daiichi Sankyo
Federal Trade Commission
Farmers Insurance
Teva

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