Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076304
Company: HOSPIRA
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 Yes
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER FLUCONAZOLE 400MG/200ML (2MG/ML) INJECTABLE;INJECTION Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/29/2004 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76304ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076304_ORIGINAL APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/24/2014 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

08/25/2008 SUPPL-9 Labeling

Label is not available on this site.

05/11/2006 SUPPL-5 Labeling

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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