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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 219282


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NDA 219282 describes GRANISETRON HYDROCHLORIDE, which is a drug marketed by Am Regent, Amneal, Baxter Hlthcare Corp, Bionpharma, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Mylan Asi, Pharmobedient, Rising, Sandoz, Sandoz Inc, Teva Pharms Usa, Wockhardt Usa, Yung Shin Pharm, Intra Sana Labs, Apotex Inc, Aurobindo Pharma Usa, Barr, Chartwell Molecular, Dr Reddys Labs Ltd, Natco Pharma, Orbion Pharms, Taro, and Teva Pharms, and is included in forty-seven NDAs. It is available from seven 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. Eight suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.
Summary for 219282
Tradename:GRANISETRON HYDROCHLORIDE
Applicant:Intra Sana Labs
Ingredient:granisetron hydrochloride
Patents:0
Pharmacology for NDA: 219282
Mechanism of ActionSerotonin 3 Receptor Antagonists
Suppliers and Packaging for NDA: 219282
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GRANISETRON HYDROCHLORIDE granisetron hydrochloride SOLUTION;ORAL 219282 ANDA Intra-Sana Laboratories 80056-801 80056-801-30 30 mL in 1 BOTTLE, GLASS (80056-801-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 2MG BASE/10ML
Approval Date:Mar 17, 2025TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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