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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076766
Company: BAXTER HLTHCARE

Products on ANDA 076766

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 076766

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/2004/76766ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/16/2024	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
07/14/2023	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
08/09/2022	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
08/09/2022	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
03/14/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
06/04/2013	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
01/14/2009	SUPPL-5	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076766

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

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