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

Last Updated: November 4, 2024

Details for New Drug Application (NDA): 213914


✉ Email this page to a colleague

« Back to Dashboard


NDA 213914 describes SUNITINIB MALATE, which is a drug marketed by Dr Reddys, Eugia Pharma, Mylan, Natco Pharma, Sun Pharm, Teva Pharms Usa, and Wanbang Biopharms, and is included in seven NDAs. It is available from eight suppliers. Additional details are available on the SUNITINIB MALATE profile page.

The generic ingredient in SUNITINIB MALATE is sunitinib malate. There are eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the sunitinib malate profile page.
Summary for 213914
Tradename:SUNITINIB MALATE
Applicant:Sun Pharm
Ingredient:sunitinib malate
Patents:0
Pharmacology for NDA: 213914
Mechanism of ActionProtein Kinase Inhibitors
Suppliers and Packaging for NDA: 213914
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUNITINIB MALATE sunitinib malate CAPSULE;ORAL 213914 ANDA NorthStar RxLLC 16714-676 16714-676-01 28 CAPSULE in 1 BOTTLE (16714-676-01)
SUNITINIB MALATE sunitinib malate CAPSULE;ORAL 213914 ANDA NorthStar RxLLC 16714-677 16714-677-01 28 CAPSULE in 1 BOTTLE (16714-677-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 12.5MG BASE
Approval Date:Aug 16, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG BASE
Approval Date:Aug 16, 2021TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 37.5MG BASE
Approval Date:Aug 16, 2021TE:ABRLD: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.