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Last Updated: July 2, 2020

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Details for New Drug Application (NDA): 020090


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NDA 020090 describes DIFLUCAN, which is a drug marketed by Pfizer and is included in three NDAs. It is available from three 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 suppliers are listed for this compound. Additional details are available on the fluconazole profile page.
Summary for 020090
Tradename:DIFLUCAN
Applicant:Pfizer
Ingredient:fluconazole
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020090
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIFLUCAN fluconazole FOR SUSPENSION;ORAL 020090 NDA Roerig 0049-3440 0049-3440-19 1 BOTTLE in 1 CARTON (0049-3440-19) > 35 mL in 1 BOTTLE
DIFLUCAN fluconazole FOR SUSPENSION;ORAL 020090 NDA Roerig 0049-3450 0049-3450-19 1 BOTTLE in 1 CARTON (0049-3450-19) > 35 mL in 1 BOTTLE
Paragraph IV (Patent) Challenges for 020090
Tradename Dosage Ingredient NDA Submissiondate
DIFLUCAN FOR SUSPENSION;ORAL fluconazole 020090

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength50MG/5ML
Approval Date:Dec 23, 1993TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength200MG/5ML
Approval Date:Dec 23, 1993TE:ABRLD:Yes

Expired US Patents for NDA 020090

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer DIFLUCAN fluconazole FOR SUSPENSION;ORAL 020090-001 Dec 23, 1993   Start Trial   Start Trial
Pfizer DIFLUCAN fluconazole FOR SUSPENSION;ORAL 020090-002 Dec 23, 1993   Start Trial   Start Trial
Pfizer DIFLUCAN fluconazole FOR SUSPENSION;ORAL 020090-002 Dec 23, 1993   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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Johnson and Johnson

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