You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: June 23, 2024

Details for New Drug Application (NDA): 210457

✉ Email this page to a colleague

« Back to Dashboard

NDA 210457 describes KETOCONAZOLE, which is a drug marketed by Padagis Israel, Xiromed, Encube, Fougera Pharms, Tasman Pharma, Teva, Tolmar, Aaipharma Llc, Aurobindo Pharma Usa, Chartwell Rx, Heritage Pharma, Senores Pharms, Strides Pharma, Sun Pharm Industries, and Taro, and is included in seventeen NDAs. It is available from twenty-four suppliers. Additional details are available on the KETOCONAZOLE profile page.

The generic ingredient in KETOCONAZOLE is ketoconazole. There are fifteen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.
Summary for 210457
Applicant:Strides Pharma
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 210457
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOCONAZOLE ketoconazole TABLET;ORAL 210457 ANDA Strides Pharma Science Limited 64380-827 64380-827-06 100 TABLET in 1 BOTTLE (64380-827-06)
KETOCONAZOLE ketoconazole TABLET;ORAL 210457 ANDA Strides Pharma Science Limited 64380-827 64380-827-07 500 TABLET in 1 BOTTLE (64380-827-07)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Jun 18, 2018TE: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.