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Last Updated: November 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019949

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NDA 019949 describes DIFLUCAN, which is a drug marketed by Pfizer and is included in three NDAs. It is available from four suppliers. Additional details are available on the DIFLUCAN profile page.

The generic ingredient in DIFLUCAN is fluconazole. There are twenty-three drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the fluconazole profile page.
Summary for 019949
Tradename:DIFLUCAN
Applicant:Pfizer
Ingredient:fluconazole
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 019949
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIFLUCAN fluconazole TABLET;ORAL 019949 NDA Roerig 0049-3410 0049-3410-30 30 TABLET in 1 BOTTLE (0049-3410-30)
DIFLUCAN fluconazole TABLET;ORAL 019949 NDA Roerig 0049-3420 0049-3420-30 30 TABLET in 1 BOTTLE (0049-3420-30)
Paragraph IV (Patent) Challenges for 019949
Tradename Dosage Ingredient NDA Submissiondate
DIFLUCAN TABLET;ORAL fluconazole 019949

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jan 29, 1990TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jan 29, 1990TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Jan 29, 1990TE:ABRLD:Yes

Expired US Patents for NDA 019949

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer DIFLUCAN fluconazole TABLET;ORAL 019949-001 Jan 29, 1990   Start Trial   Start Trial
Pfizer DIFLUCAN fluconazole TABLET;ORAL 019949-002 Jan 29, 1990   Start Trial   Start Trial
Pfizer DIFLUCAN fluconazole TABLET;ORAL 019949-004 Jun 30, 1994   Start Trial   Start Trial
Pfizer DIFLUCAN fluconazole TABLET;ORAL 019949-003 Jan 29, 1990   Start Trial   Start Trial
Pfizer DIFLUCAN fluconazole TABLET;ORAL 019949-003 Jan 29, 1990   Start Trial   Start Trial
Pfizer DIFLUCAN fluconazole TABLET;ORAL 019949-004 Jun 30, 1994   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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