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Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202395

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NDA 202395 describes ZIPRASIDONE HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Lupin Pharms, Macleods Pharms Ltd, Mylan Pharms Inc, Sandoz Inc, Wockhardt Ltd, and Zydus Pharms Usa Inc, and is included in nine NDAs. It is available from twenty-seven suppliers. Additional details are available on the ZIPRASIDONE HYDROCHLORIDE profile page.

The generic ingredient in ZIPRASIDONE HYDROCHLORIDE is ziprasidone hydrochloride. There are twenty-one drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the ziprasidone hydrochloride profile page.
Summary for 202395
Tradename:ZIPRASIDONE HYDROCHLORIDE
Applicant:Mylan Pharms Inc
Ingredient:ziprasidone hydrochloride
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 202395
Suppliers and Packaging for NDA: 202395
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride CAPSULE;ORAL 202395 ANDA Mylan Pharmaceuticals Inc. 0378-7353 N 0378-7353-05
ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride CAPSULE;ORAL 202395 ANDA Mylan Pharmaceuticals Inc. 0378-7353 N 0378-7353-91

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 20MG BASE
Approval Date:Oct 10, 2013TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 40MG BASE
Approval Date:Oct 10, 2013TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 60MG BASE
Approval Date:Oct 10, 2013TE:RLD:No

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