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Last Updated: November 17, 2019

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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 two suppliers. 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. Ten 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
Formulation / Manufacturing:see details
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 0069-5800-43 40 BLISTER PACK in 1 CARTON (0069-5800-43) > 1 CAPSULE in 1 BLISTER PACK
TIKOSYN dofetilide CAPSULE;ORAL 020931 NDA Pfizer Laboratories Div Pfizer Inc 0069-5800 0069-5800-60 60 CAPSULE in 1 BOTTLE (0069-5800-60)
Paragraph IV (Patent) Challenges for 020931
Tradename Dosage Ingredient NDA Submissiondate
TIKOSYN CAPSULE;ORAL dofetilide 020931 2014-05-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.125MG
Approval Date:Oct 1, 1999TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.25MG
Approval Date:Oct 1, 1999TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MG
Approval Date:Oct 1, 1999TE:ABRLD:Yes

Expired US Patents for NDA 020931

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

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