Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 077909

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FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (FLUCONAZOLE)
100MG/50ML (2MG/ML)
Marketing Status: Prescription

Active Ingredient: FLUCONAZOLE
Proprietary Name: FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 100MG/50ML (2MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A077909
Product Number: 003
Approval Date: Apr 20, 2015
Applicant Holder Full Name: WOODWARD PHARMA SERVICES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (FLUCONAZOLE)
200MG/100ML (2MG/ML)
Marketing Status: Prescription

Active Ingredient: FLUCONAZOLE
Proprietary Name: FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 200MG/100ML (2MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A077909
Product Number: 001
Approval Date: May 26, 2010
Applicant Holder Full Name: WOODWARD PHARMA SERVICES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (FLUCONAZOLE)
400MG/200ML (2MG/ML)
Marketing Status: Prescription

Active Ingredient: FLUCONAZOLE
Proprietary Name: FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 400MG/200ML (2MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A077909
Product Number: 002
Approval Date: May 26, 2010
Applicant Holder Full Name: WOODWARD PHARMA SERVICES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information