➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Merck
Express Scripts
Harvard Business School
Medtronic
Baxter
Colorcon

Last Updated: July 12, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078566


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 078566 describes GRANISETRON HYDROCHLORIDE, which is a drug marketed by Akorn Inc, Am Regent, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Bionpharma Inc, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Mylan Asi, Mylan Labs Ltd, Puniska, 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 078566
Tradename:GRANISETRON HYDROCHLORIDE
Applicant:Wockhardt Usa
Ingredient:granisetron hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078566
Suppliers and Packaging for NDA: 078566
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078566 ANDA Wockhardt USA LLC. 64679-662 64679-662-01 5 VIAL, SINGLE-USE in 1 CARTON (64679-662-01) > 1 mL in 1 VIAL, SINGLE-USE (64679-662-03)
GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078566 ANDA Wockhardt USA LLC. 64679-662 64679-662-02 1 VIAL, SINGLE-USE in 1 CARTON (64679-662-02) > 1 mL in 1 VIAL, SINGLE-USE (64679-662-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
Approval Date:Feb 29, 2008TE:APRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
AstraZeneca
Johnson and Johnson
McKinsey
Moodys
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.