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Generated: May 27, 2019

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Details for New Drug Application (NDA): 078096

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NDA 078096 describes GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Bluepharma, Fresenius Kabi Usa, and Teva Pharms Usa, and is included in three NDAs. It is available from one supplier. Additional details are available on the GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE profile page.

The generic ingredient in GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE is granisetron hydrochloride. There are twenty-six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.
Summary for 078096
Applicant:Fresenius Kabi Usa
Ingredient:granisetron hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 078096
Suppliers and Packaging for NDA: 078096
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE granisetron hydrochloride INJECTABLE;INJECTION 078096 ANDA Fresenius Kabi USA, LLC 63323-318 63323-318-01 1 VIAL, SINGLE-USE in 1 BOX (63323-318-01) > 1 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Approval Date:Jun 30, 2008TE:APRLD:No

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