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Last Updated: June 14, 2024

Details for New Drug Application (NDA): 020825


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NDA 020825 describes GEODON, which is a drug marketed by Viatris and Pfizer Inc and is included in three NDAs. It is available from three suppliers. Additional details are available on the GEODON profile page.

The generic ingredient in GEODON is ziprasidone mesylate. There are twenty-three drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ziprasidone mesylate profile page.
Summary for 020825
Tradename:GEODON
Applicant:Viatris
Ingredient:ziprasidone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020825
Suppliers and Packaging for NDA: 020825
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEODON ziprasidone hydrochloride CAPSULE;ORAL 020825 NDA ROERIG 0049-0056 0049-0056-60 60 CAPSULE in 1 BOTTLE (0049-0056-60)
GEODON ziprasidone hydrochloride CAPSULE;ORAL 020825 NDA ROERIG 0049-0058 0049-0058-60 60 CAPSULE in 1 BOTTLE (0049-0058-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 20MG BASE
Approval Date:Feb 5, 2001TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Jan 28, 2025
Regulatory Exclusivity Use:INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 40MG BASE
Approval Date:Feb 5, 2001TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Jan 28, 2025
Regulatory Exclusivity Use:INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 60MG BASE
Approval Date:Feb 5, 2001TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Jan 28, 2025
Regulatory Exclusivity Use:INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES

Expired US Patents for NDA 020825

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viatris GEODON ziprasidone hydrochloride CAPSULE;ORAL 020825-004 Feb 5, 2001 ⤷  Sign Up ⤷  Sign Up
Viatris GEODON ziprasidone hydrochloride CAPSULE;ORAL 020825-004 Feb 5, 2001 ⤷  Sign Up ⤷  Sign Up
Viatris GEODON ziprasidone hydrochloride CAPSULE;ORAL 020825-001 Feb 5, 2001 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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