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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 eight 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-seven suppliers are listed for this compound. Additional details are available on the fluconazole profile page.

Summary for NDA: 019949

Tradename:
DIFLUCAN
Applicant:
Pfizer
Ingredient:
fluconazole
Patents:0
Therapeutic Class:Antifungals
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jan 29, 1990TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jan 29, 1990TE:ABRLD:No

Summary for product number 003

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

Expired Orange Book Patents for NDA: 019949

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
DIFLUCAN
fluconazole
TABLET;ORAL019949-003Jan 29, 19904,404,216*PED► subscribe
Pfizer
DIFLUCAN
fluconazole
TABLET;ORAL019949-003Jan 29, 19904,416,682► subscribe
Pfizer
DIFLUCAN
fluconazole
TABLET;ORAL019949-001Jan 29, 19904,404,216*PED► subscribe
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