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Clozapineis the generic ingredient in four branded drugs marketed by Tasman Pharma, Barr Labs Inc, Mylan, Teva Pharms Usa, Jazz, Accord Hlthcare, Aurobindo Pharma Ltd, Ivax Sub Teva Pharms, Mayne Pharma, Par Pharm, Sandoz, Sun Pharm Inds Inc, Zydus Pharms, and Heritage Life, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.
There are thirteen drug master file entries for clozapine. Sixteen suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for clozapine
|Drug Master File Entries:||13|
|Suppliers / Packagers:||16|
|Bulk Api Vendors:||97|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price trends for clozapine|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for clozapine|
|DailyMed Link:||clozapine at DailyMed|
Pharmacology for clozapine
|Drug Class||Atypical Antipsychotic |
Medical Subject Heading (MeSH) Categories for clozapine
Generic filers with tentative approvals for CLOZAPINE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Mylan||CLOZAPINE||clozapine||TABLET;ORAL||075417-005||Apr 15, 2010||AB||RX||No||No||Try a Free Trial||Try a Free Trial||Try a Free Trial|
|Jazz||FAZACLO ODT||clozapine||TABLET, ORALLY DISINTEGRATING;ORAL||021590-001||Feb 10, 2004||AB||RX||Yes||No||Try a Free Trial||Try a Free Trial||Try a Free Trial|
|Mayne Pharma||CLOZAPINE||clozapine||TABLET;ORAL||203807-004||Aug 22, 2017||AB||RX||No||No||Try a Free Trial||Try a Free Trial||Try a Free Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Patent No.||Patent Expiration|
|Jazz||FAZACLO ODT||clozapine||TABLET, ORALLY DISINTEGRATING;ORAL||021590-006||Jul 9, 2010||Try a Free Trial||Try a Free Trial|
|Jazz||FAZACLO ODT||clozapine||TABLET, ORALLY DISINTEGRATING;ORAL||021590-002||Feb 10, 2004||Try a Free Trial||Try a Free Trial|
|Jazz||FAZACLO ODT||clozapine||TABLET, ORALLY DISINTEGRATING;ORAL||021590-004||May 30, 2007||Try a Free Trial||Try a Free Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
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