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Last Updated: April 17, 2024

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 one supplier. 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. Fifteen 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 HLS Therapeutics (USA), Inc. 69809-0126 69809-0126-5 100 TABLET in 1 BOTTLE (69809-0126-5)
CLOZARIL clozapine TABLET;ORAL 019758 NDA HLS Therapeutics (USA), Inc. 69809-0127 69809-0127-5 100 TABLET in 1 BOTTLE (69809-0127-5)

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

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:May 20, 2019TE:ABRLD:Yes

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