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Generated: December 16, 2018

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Details for New Drug Application (NDA): 203479

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NDA 203479 describes VERSACLOZ, which is a drug marketed by Tasman Pharma and is included in one NDA. It is available from two suppliers. Additional details are available on the VERSACLOZ profile page.

The generic ingredient in VERSACLOZ 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 203479
Tradename:VERSACLOZ
Applicant:Tasman Pharma
Ingredient:clozapine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203479
Medical Subject Heading (MeSH) Categories for 203479
Suppliers and Packaging for NDA: 203479
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VERSACLOZ clozapine SUSPENSION;ORAL 203479 NDA Jazz Pharmaceuticals, Inc. 18860-121 18860-121-01 1 BOTTLE in 1 BOX (18860-121-01) > 100 mL in 1 BOTTLE
VERSACLOZ clozapine SUSPENSION;ORAL 203479 NDA TruPharma, LLC 52817-601 52817-601-38 1 BOTTLE in 1 BOX (52817-601-38) > 100 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength50MG/ML
Approval Date:Feb 6, 2013TE:RLD:Yes

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