Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077988
Company: WOODWARD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER FLUCONAZOLE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Prescription AP No No
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER FLUCONAZOLE 400MG/200ML (2MG/ML) INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/26/2010 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/10/2014 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

11/10/2014 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 200MG/100ML (2MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER FLUCONAZOLE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 078764 HIKMA FARMACEUTICA
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER FLUCONAZOLE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 076304 HOSPIRA
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER FLUCONAZOLE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 077988 WOODWARD
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% FLUCONAZOLE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 077947 BAXTER HLTHCARE CORP
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% FLUCONAZOLE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 076145 FRESENIUS KABI USA
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% FLUCONAZOLE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 076736 HIKMA FARMACEUTICA
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% FLUCONAZOLE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 076087 WEST-WARD PHARMS INT
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FLUCONAZOLE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 076766 BAXTER HLTHCARE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FLUCONAZOLE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 078698 HIKMA FARMACEUTICA
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FLUCONAZOLE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 076303 HOSPIRA
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FLUCONAZOLE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 079104 INFORLIFE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FLUCONAZOLE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 078107 WEST-WARD PHARMS INT
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FLUCONAZOLE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 077909 WOODWARD

INJECTABLE;INJECTION; 400MG/200ML (2MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER FLUCONAZOLE 400MG/200ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 078764 HIKMA FARMACEUTICA
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER FLUCONAZOLE 400MG/200ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 076304 HOSPIRA
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER FLUCONAZOLE 400MG/200ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 077988 WOODWARD
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% FLUCONAZOLE 400MG/200ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 077947 BAXTER HLTHCARE CORP
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% FLUCONAZOLE 400MG/200ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 076145 FRESENIUS KABI USA
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% FLUCONAZOLE 400MG/200ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 076087 WEST-WARD PHARMS INT
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FLUCONAZOLE 400MG/200ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 076766 BAXTER HLTHCARE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FLUCONAZOLE 400MG/200ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 078698 HIKMA FARMACEUTICA
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FLUCONAZOLE 400MG/200ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 076303 HOSPIRA
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FLUCONAZOLE 400MG/200ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 079104 INFORLIFE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FLUCONAZOLE 400MG/200ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 078107 WEST-WARD PHARMS INT
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FLUCONAZOLE 400MG/200ML (2MG/ML) INJECTABLE;INJECTION Prescription No AP 077909 WOODWARD

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