BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Express Scripts
Federal Trade Commission
Harvard Business School
Farmers Insurance

Generated: November 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090658

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NDA 090658 describes GANCICLOVIR, which is a drug marketed by Luitpold Pharms Inc, Exela Pharma Scs Llc, Par Sterile Products, Ranbaxy Labs Ltd, Fresenius Kabi Usa, and West-ward Pharms Int, and is included in six NDAs. It is available from five suppliers. There is one patent protecting this drug. Additional details are available on the GANCICLOVIR profile page.

The generic ingredient in GANCICLOVIR is ganciclovir . There are twenty-five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ganciclovir profile page.

Summary for 090658

Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 090658

Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors

Medical Subject Heading (MeSH) Categories for 090658

Suppliers and Packaging for NDA: 090658

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ganciclovir sodium
INJECTABLE;INJECTION 090658 ANDA Fresenius Kabi USA, LLC 63323-315 63323-315-94 25 VIAL in 1 TRAY (63323-315-94) > 10 mL in 1 VIAL
ganciclovir sodium
INJECTABLE;INJECTION 090658 ANDA Fresenius Kabi USA, LLC 63323-315 63323-315-10 25 VIAL in 1 TRAY (63323-315-10) > 10 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Jun 21, 2010TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Boehringer Ingelheim
Daiichi Sankyo
Chinese Patent Office
US Department of Justice

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