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Serving 500+ biopharmaceutical companies globally:

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Generated: September 23, 2017

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 Aurobindo Pharma Ltd, Wockhardt Ltd, Lupin Pharms, Apotex Inc, Sandoz Inc, Dr Reddys Labs Inc, Macleods Pharms Ltd, Zydus Pharms Usa Inc, and Mylan Pharms 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-three suppliers are listed for this compound. Additional details are available on the ziprasidone hydrochloride profile page.

Summary for NDA: 077562

Tradename:
1
Applicant:
1
Ingredient:
1
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)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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