Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson

Generated: January 16, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204950

« Back to Dashboard

NDA 204950 describes GANCICLOVIR, which is a drug marketed by Ranbaxy Labs Ltd, Fresenius Kabi Usa, Hainan Poly Pharm, Luitpold, Mylan Labs Ltd, Par Sterile Products, Exela Pharma Scs Llc, Pharmascience Inc, and West-ward Pharms Int, and is included in nine NDAs. It is available from four suppliers. There is one patent protecting this drug. Additional details are available on the GANCICLOVIR profile page.

The generic ingredient in GANCICLOVIR is ganciclovir sodium. There are twenty-seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the ganciclovir sodium profile page.
Summary for 204950
Applicant:Par Sterile Products
Ingredient:ganciclovir sodium
Formulation / Manufacturing:see details
Pharmacology for NDA: 204950
Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors
Suppliers and Packaging for NDA: 204950
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GANCICLOVIR ganciclovir sodium INJECTABLE;INJECTION 204950 ANDA Par Pharmaceutical, Inc. 42023-173 42023-173-25 25 VIAL, SINGLE-DOSE in 1 CARTON (42023-173-25) > 10 mL in 1 VIAL, SINGLE-DOSE (42023-173-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Dec 6, 2016TE:APRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Queensland Health
Harvard Business School
Cantor Fitzgerald

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.