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Last Updated: November 13, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078258

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NDA 078258 describes GRANISETRON HYDROCHLORIDE, which is a drug marketed by Akorn Inc, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Bionpharma Inc, Cipla Ltd, Dr Reddys, 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, and Teva Pharms, and is included in forty-four NDAs. It is available from fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.
Summary for 078258
Tradename:GRANISETRON HYDROCHLORIDE
Applicant:Cipla Ltd
Ingredient:granisetron hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078258
Suppliers and Packaging for NDA: 078258
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078258 ANDA Cipla USA Inc. 69097-196 69097-196-67 1 mL in 1 VIAL, SINGLE-USE (69097-196-67)
GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078258 ANDA Cipla USA Inc. 69097-197 69097-197-67 4 mL in 1 VIAL, MULTI-DOSE (69097-197-67)

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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 4MG BASE/4ML (EQ 1MG BASE/ML)
Approval Date:Jun 30, 2008TE:APRLD:No

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