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Last Updated: January 21, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079078

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NDA 079078 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, Hikma, Mylan, Natco Pharma, Orchid Hlthcare, Taro, and Teva Pharms, and is included in forty-four NDAs. It is available from thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.
Summary for 079078
Tradename:GRANISETRON HYDROCHLORIDE
Applicant:Akorn Inc
Ingredient:granisetron hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 079078
Suppliers and Packaging for NDA: 079078
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 079078 ANDA Akorn, Inc. 17478-546 17478-546-02 1 VIAL, SINGLE-DOSE in 1 CARTON (17478-546-02) > 1 mL in 1 VIAL, SINGLE-DOSE
GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 079078 ANDA Akorn, Inc. 17478-546 17478-546-05 1 VIAL, MULTI-DOSE in 1 CARTON (17478-546-05) > 4 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1MG BASE/ML (EQ 1MG BASE/ML)
Approval Date:Sep 14, 2009TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 4MG BASE/4ML (EQ 1MG BASE/ML)
Approval Date:Sep 14, 2009TE:APRLD:No

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