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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 four suppliers. Additional details are available on the CLOZARIL profile page.

The generic ingredient in CLOZARIL is clozapine. There are twelve drug master file entries for this compound. Fourteen suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the clozapine profile page.

Summary for NDA: 019758

Heritage Life
Therapeutic Class:Antipsychotics

Pharmacology for NDA: 019758

Suppliers and Packaging for NDA: 019758

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 019758 NDA Novartis Pharmaceuticals Corporation 0078-0126 0078-0126-05 100 TABLET in 1 BOTTLE (0078-0126-05)
TABLET;ORAL 019758 NDA Novartis Pharmaceuticals Corporation 0078-0126 0078-0126-06 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0126-06) > 1 TABLET in 1 BLISTER PACK (0078-0126-61)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Sep 26, 1989TE:ABRLD:No

Summary for product number 002

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

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