Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Check market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077565

« Back to Dashboard
NDA 077565 describes ZIPRASIDONE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Wockhardt Ltd, Lupin Pharms, Apotex Inc, Sandoz Inc, Dr Reddys Labs Inc, and Mylan Pharms Inc, and is included in seven NDAs. It is available from twenty-three 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. Twenty-nine suppliers are listed for this compound. Additional details are available on the ziprasidone hydrochloride profile page.

Summary for NDA: 077565

Dr Reddys Labs Inc
ziprasidone hydrochloride
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077565

Suppliers and Packaging for NDA: 077565

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ziprasidone hydrochloride
CAPSULE;ORAL 077565 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7703 0615-7703-39 30 CAPSULE in 1 BLISTER PACK (0615-7703-39)
ziprasidone hydrochloride
CAPSULE;ORAL 077565 ANDA Major Pharmaceuticals 0904-6269 0904-6269-08 40 CAPSULE in 1 BOX, UNIT-DOSE (0904-6269-08)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 20MG BASE
Approval Date:Mar 2, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 40MG BASE
Approval Date:Mar 2, 2012TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 60MG BASE
Approval Date:Mar 2, 2012TE:ABRLD:No

Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

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.