➤ Get the DrugPatentWatch Daily Briefing

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

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts

Last Updated: July 14, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204238

Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 204238 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 204238
Applicant:Aurobindo Pharma Ltd
Ingredient:granisetron hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 204238
Suppliers and Packaging for NDA: 204238
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 204238 ANDA AuroMedics Pharma LLC 55150-175 55150-175-01 1 VIAL, SINGLE-USE in 1 CARTON (55150-175-01) > 1 mL in 1 VIAL, SINGLE-USE
GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 204238 ANDA AuroMedics Pharma LLC 55150-176 55150-176-04 1 VIAL, MULTI-DOSE in 1 CARTON (55150-176-04) > 4 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Approval Date:Jul 6, 2016TE:APRLD:No

Profile for product number 002

Approval Date:Jul 6, 2016TE:APRLD:No

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Harvard Business School

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.