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Details for New Drug Application (NDA): 077561

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NDA 077561 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-four 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 NDA: 077561

Apotex Inc
ziprasidone hydrochloride
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077561

Suppliers and Packaging for NDA: 077561

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ziprasidone hydrochloride
CAPSULE;ORAL 077561 ANDA A-S Medication Solutions 50090-2704 50090-2704-0 40 BLISTER PACK in 1 BOX, UNIT-DOSE (50090-2704-0) > 1 CAPSULE in 1 BLISTER PACK
ziprasidone hydrochloride
CAPSULE;ORAL 077561 ANDA Clinical Solutions Wholesale 58118-2528 58118-2528-8 30 CAPSULE in 1 BLISTER PACK (58118-2528-8)

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

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