Details for New Drug Application (NDA): 020931

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NDA 020931 describes TIKOSYN, which is a drug marketed by Pfizer and is included in one NDA. It is available from one supplier. Additional details are available on the TIKOSYN profile page.

The generic ingredient in TIKOSYN is dofetilide. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dofetilide profile page.

Summary for 020931

Tradename:	TIKOSYN
Applicant:	Pfizer
Ingredient:	dofetilide
Patents:	0

Pharmacology for NDA: 020931

Suppliers and Packaging for NDA: 020931

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TIKOSYN	dofetilide	CAPSULE;ORAL	020931	NDA	Pfizer Laboratories Div Pfizer Inc	0069-5800	0069-5800-60	60 CAPSULE in 1 BOTTLE (0069-5800-60)
TIKOSYN	dofetilide	CAPSULE;ORAL	020931	NDA	Pfizer Laboratories Div Pfizer Inc	0069-5800	0069-5800-61	14 CAPSULE in 1 BOTTLE (0069-5800-61)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.125MG
Approval Date:	Oct 1, 1999	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.25MG
Approval Date:	Oct 1, 1999	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.5MG
Approval Date:	Oct 1, 1999	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020931

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931-001	Oct 1, 1999	4,959,366	⤷ Start Trial
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931-003	Oct 1, 1999	6,124,363	⤷ Start Trial
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931-001	Oct 1, 1999	6,124,363	⤷ Start Trial
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931-003	Oct 1, 1999	4,959,366	⤷ Start Trial
Pfizer	TIKOSYN	dofetilide	CAPSULE;ORAL	020931-002	Oct 1, 1999	6,124,363	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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