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McKinsey
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Harvard Business School
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Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078522

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NDA 078522 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, 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 eighteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.
Summary for 078522
Tradename:GRANISETRON HYDROCHLORIDE
Applicant:Fresenius Kabi Usa
Ingredient:granisetron hydrochloride
Patents:0
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details
Pharmacology for NDA: 078522
Suppliers and Packaging for NDA: 078522
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078522 ANDA Fresenius Kabi USA, LLC 63323-317 N 63323-317-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
Approval Date:Dec 31, 2007TE:APRLD:No

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