An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076303
Company: HOSPIRA

Products on ANDA 076303

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE	200MG/100ML (2MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE	400MG/200ML (2MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076303

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)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76303ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/17/2023	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
07/17/2023	SUPPL-25	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
05/12/2021	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
05/12/2021	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
05/12/2021	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
05/12/2021	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
05/12/2021	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
05/12/2021	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
03/24/2014	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
08/25/2008	SUPPL-10	Labeling		Label is not available on this site.
05/11/2006	SUPPL-6	Labeling		Label is not available on this site.
03/23/2006	SUPPL-5	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076303

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% 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 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	076087	HIKMA
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% 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 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	HIKMA
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

Top