You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: October 16, 2024

Details for New Drug Application (NDA): 078011


✉ Email this page to a colleague

« Back to Dashboard


NDA 078011 describes VINORELBINE TARTRATE, which is a drug marketed by Actavis Totowa, Dr Reddys, Ebewe Pharma, Fresenius Kabi Usa, Hikma, Hospira, Jiangsu Hansoh Pharm, Novast Labs, Rising, and Teva Pharms Usa, and is included in eleven NDAs. It is available from two suppliers. Additional details are available on the VINORELBINE TARTRATE profile page.

The generic ingredient in VINORELBINE TARTRATE is vinorelbine tartrate. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the vinorelbine tartrate profile page.
Summary for 078011
Tradename:VINORELBINE TARTRATE
Applicant:Actavis Totowa
Ingredient:vinorelbine tartrate
Patents:0
Pharmacology for NDA: 078011
Suppliers and Packaging for NDA: 078011
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VINORELBINE TARTRATE vinorelbine tartrate INJECTABLE;INJECTION 078011 ANDA Actavis Pharma, Inc. 45963-607 45963-607-55 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-607-55) / 1 mL in 1 VIAL, SINGLE-DOSE
VINORELBINE TARTRATE vinorelbine tartrate INJECTABLE;INJECTION 078011 ANDA Actavis Pharma, Inc. 45963-607 45963-607-56 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-607-56) / 5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10MG BASE/ML
Approval Date:Jul 22, 2009TE:APRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.