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Details for New Drug Application (NDA): 090348

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NDA 090348 describes ZIPRASIDONE HYDROCHLORIDE, which is a drug marketed by Wockhardt Ltd, Lupin Pharms, Apotex Corp, Sandoz Inc, Dr Reddys Labs Inc, and Mylan Pharms Inc, and is included in six NDAs. It is available from twenty-two suppliers. Additional details are available on the ZIPRASIDONE HYDROCHLORIDE profile page.

The generic ingredient in ZIPRASIDONE HYDROCHLORIDE is ziprasidone hydrochloride. There are twenty drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ziprasidone hydrochloride profile page.

Summary for NDA: 090348

Tradename:
ZIPRASIDONE HYDROCHLORIDE
Applicant:
Wockhardt Ltd
Ingredient:
ziprasidone hydrochloride
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090348

Suppliers and Packaging for NDA: 090348

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochloride
CAPSULE;ORAL 090348 ANDA Wockhardt Limited 55648-991 55648-991-01 30 CAPSULE in 1 BOTTLE (55648-991-01)
ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochloride
CAPSULE;ORAL 090348 ANDA Wockhardt Limited 55648-991 55648-991-02 60 CAPSULE in 1 BOTTLE (55648-991-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 20MG BASE
Approval Date:Sep 5, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 40MG BASE
Approval Date:Sep 5, 2012TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 60MG BASE
Approval Date:Sep 5, 2012TE:ABRLD:No


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