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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 090348


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NDA 090348 describes ZIPRASIDONE HYDROCHLORIDE, which is a drug marketed by Apotex, Aurobindo Pharma, Chartwell Rx, Dr Reddys Labs Inc, Lupin Pharms, Macleods Pharms Ltd, Mylan, Sandoz Inc, and Zydus Lifesciences, and is included in nine NDAs. It is available from twenty suppliers. Additional details are available on the ZIPRASIDONE HYDROCHLORIDE profile page.

The generic ingredient in ZIPRASIDONE HYDROCHLORIDE is ziprasidone hydrochloride. There are twenty-three drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ziprasidone hydrochloride profile page.
Summary for 090348
Tradename:ZIPRASIDONE HYDROCHLORIDE
Applicant:Chartwell Rx
Ingredient:ziprasidone hydrochloride
Patents:0
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 Chartwell RX, LLC 62135-991 62135-991-60 60 CAPSULE in 1 BOTTLE (62135-991-60)
ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride CAPSULE;ORAL 090348 ANDA Chartwell RX, LLC 62135-992 62135-992-60 60 CAPSULE in 1 BOTTLE (62135-992-60)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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