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Generated: August 26, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078566

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NDA 078566 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 Pharm, and Teva Pharms, and is included in forty-four NDAs. It is available from sixteen 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. Sixteen 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 LIMITED 55648-662 55648-662-01 5 CARTON in 1 CARTON (55648-662-01) > 1 VIAL, SINGLE-USE in 1 CARTON (55648-662-02) > 1 mL in 1 VIAL, SINGLE-USE
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)

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

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