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 four 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	0049-0052	0049-0052-60	60 CAPSULE in 1 BOTTLE (0049-0052-60)
GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825	NDA	Roerig	0049-0054	0049-0054-60	60 CAPSULE in 1 BOTTLE (0049-0054-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 20MG BASE
Approval Date:	Feb 5, 2001	TE:	AB	RLD:	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:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 40MG BASE
Approval Date:	Feb 5, 2001	TE:	AB	RLD:	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:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 60MG BASE
Approval Date:	Feb 5, 2001	TE:	AB	RLD:	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-004	Feb 5, 2001	See Plans and Pricing	See Plans and Pricing
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-003	Feb 5, 2001	See Plans and Pricing	See Plans and Pricing
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-001	Feb 5, 2001	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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