You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: April 1, 2026

Details for New Drug Application (NDA): 218559

✉ Email this page to a colleague

« Back to Dashboard

NDA 218559 describes KETOCONAZOLE, which is a drug marketed by Padagis Israel, Xiromed, Encube, Fougera Pharms, Padagis Us, Teva, Cosette, Novitium Pharma, Zydus Lifesciences, Aaipharma Llc, Aurobindo Pharma Usa, Chartwell Rx, Heritage Pharma, Senores Pharms, Strides Pharma, Sun Pharm Industries, and Taro, and is included in twenty NDAs. It is available from thirty 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. Thirty-one suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.

Summary for 218559

Tradename:	KETOCONAZOLE
Applicant:	Zydus Lifesciences
Ingredient:	ketoconazole
Patents:	0

Pharmacology for NDA: 218559

Mechanism of Action	Cytochrome P450 3A4 Inhibitors Cytochrome P450 3A5 Inhibitors P-Glycoprotein Inhibitors

Medical Subject Heading (MeSH) Categories for 218559

14-alpha Demethylase Inhibitors
Antifungal Agents
Cytochrome P-450 CYP3A Inhibitors

Suppliers and Packaging for NDA: 218559

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KETOCONAZOLE	ketoconazole	SHAMPOO;TOPICAL	218559	ANDA	Zydus Lifesciences Limited	70771-1874	70771-1874-7	120 mL in 1 BOTTLE (70771-1874-7)
KETOCONAZOLE	ketoconazole	SHAMPOO;TOPICAL	218559	ANDA	Viona Pharmaceuticals Inc	72578-156	72578-156-12	120 mL in 1 BOTTLE (72578-156-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SHAMPOO;TOPICAL			Strength	2%
Approval Date:	Mar 7, 2025	TE:	AB	RLD:	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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.