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Serving leading biopharmaceutical companies globally:

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Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077562

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NDA 077562 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-nine 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-five suppliers are listed for this compound. Additional details are available on the ziprasidone hydrochloride profile page.
Summary for 077562
Tradename:ZIPRASIDONE HYDROCHLORIDE
Applicant:Sandoz Inc
Ingredient:ziprasidone hydrochloride
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077562
Suppliers and Packaging for NDA: 077562
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride CAPSULE;ORAL 077562 ANDA Sandoz Inc 0781-2164 0781-2164-60 60 CAPSULE in 1 BOTTLE (0781-2164-60)
ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride CAPSULE;ORAL 077562 ANDA Sandoz Inc 0781-2166 0781-2166-60 60 CAPSULE in 1 BOTTLE (0781-2166-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 20MG BASE
Approval Date:Jun 1, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 40MG BASE
Approval Date:Jun 1, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 60MG BASE
Approval Date:Jun 1, 2012TE:ABRLD:No

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