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

Last Updated: March 19, 2026

Details for New Drug Application (NDA): 075417

✉ Email this page to a colleague

« Back to Dashboard

NDA 075417 describes CLOZAPINE, which is a drug marketed by Aurobindo Pharma, Barr Labs Inc, Mylan, Accord Hlthcare, Dr Reddys Labs Sa, Ivax Sub Teva Pharms, Par Pharm, Sandoz, Sun Pharm Inds Inc, and Zydus Pharms, and is included in thirteen NDAs. It is available from eleven suppliers. Additional details are available on the CLOZAPINE profile page.

The generic ingredient in CLOZAPINE is clozapine. There are thirteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the clozapine profile page.

Summary for 075417

Tradename:	CLOZAPINE
Applicant:	Mylan
Ingredient:	clozapine
Patents:	0

Pharmacology for NDA: 075417

Medical Subject Heading (MeSH) Categories for 075417

Antipsychotic Agents
GABA Antagonists
Serotonin Antagonists

Suppliers and Packaging for NDA: 075417

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOZAPINE	clozapine	TABLET;ORAL	075417	ANDA	Mylan Pharmaceuticals Inc.	0378-0825	0378-0825-01	100 TABLET in 1 BOTTLE, PLASTIC (0378-0825-01)
CLOZAPINE	clozapine	TABLET;ORAL	075417	ANDA	Mylan Pharmaceuticals Inc.	0378-0860	0378-0860-01	100 TABLET in 1 BOTTLE, PLASTIC (0378-0860-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	May 27, 1999	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	May 27, 1999	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	12.5MG
Approval Date:	Apr 15, 2010	TE:		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.