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Harvard Business School
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Boehringer Ingelheim
Federal Trade Commission
Argus Health
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Generated: January 23, 2019

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Details for New Drug Application (NDA): 019758

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NDA 019758 describes CLOZARIL, which is a drug marketed by Heritage Life and is included in one NDA. It is available from three suppliers. Additional details are available on the CLOZARIL profile page.

The generic ingredient in CLOZARIL is clozapine. There are thirteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the clozapine profile page.
Summary for 019758
Applicant:Heritage Life
Formulation / Manufacturing:see details
Pharmacology for NDA: 019758
Medical Subject Heading (MeSH) Categories for 019758
Suppliers and Packaging for NDA: 019758
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOZARIL clozapine TABLET;ORAL 019758 NDA Sandoz Inc. 0781-5989 0781-5989-01 100 TABLET in 1 BOTTLE (0781-5989-01)
CLOZARIL clozapine TABLET;ORAL 019758 NDA Sandoz Inc. 0781-5992 0781-5992-01 100 TABLET in 1 BOTTLE (0781-5992-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Sep 26, 1989TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Sep 26, 1989TE:ABRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Fish and Richardson
Daiichi Sankyo

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