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Details for New Drug Application (NDA): 019950

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NDA 019950 describes DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by Pfizer and is included in one NDA. Additional details are available on the DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER profile page.

The generic ingredient in DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 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: 019950

Tradename:
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
Applicant:
Pfizer
Ingredient:
fluconazole
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/100ML (2MG/ML)
Approval Date:Jan 29, 1990TE:APRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/100ML (2MG/ML)
Approval Date:Jan 29, 1990TE:APRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/100ML (2MG/ML)
Approval Date:Sep 29, 1992TE:APRLD:Yes

Expired Orange Book Patents for NDA: 019950

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
fluconazole
INJECTABLE;INJECTION019950-003Sep 29, 19924,404,216*PED► subscribe
Pfizer
DIFLUCAN IN SODIUM CHLORIDE 0.9%
fluconazole
INJECTABLE;INJECTION019950-001Jan 29, 19904,416,682► subscribe
Pfizer
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
fluconazole
INJECTABLE;INJECTION019950-004Jan 29, 19904,404,216*PED► subscribe
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