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): 076507
Company: TARO

Products on ANDA 076507

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET;ORAL	Prescription	AB	No	No
FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET;ORAL	Prescription	AB	No	No
FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET;ORAL	Prescription	AB	No	No
FLUCONAZOLE	FLUCONAZOLE	200MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076507

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/2004/76507ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/19/2015	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
03/19/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
03/19/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
04/18/2012	SUPPL-4	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
12/16/2011	SUPPL-3	Labeling-Patient Package Insert		Label is not available on this site.
11/06/2008	SUPPL-2	Labeling		Label is not available on this site.
01/09/2008	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 076507

FLUCONAZOLE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIFLUCAN	FLUCONAZOLE	50MG	TABLET;ORAL	Prescription	Yes	AB	019949	PFIZER
FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET;ORAL	Prescription	No	AB	078423	ANI PHARMS
FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET;ORAL	Prescription	No	AB	077731	AUROBINDO PHARMA
FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET;ORAL	Prescription	No	AB	076665	CHARTWELL
FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET;ORAL	Prescription	No	AB	076658	DR REDDYS LABS INC
FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET;ORAL	Prescription	No	AB	077253	GLENMARK GENERICS
FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET;ORAL	Prescription	No	AB	076077	IVAX SUB TEVA PHARMS
FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET;ORAL	Prescription	No	AB	076507	TARO
FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET;ORAL	Prescription	No	AB	076957	THINQ PHARM-CRO PVT
FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET;ORAL	Prescription	No	AB	208963	ZYDUS PHARMS

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIFLUCAN	FLUCONAZOLE	100MG	TABLET;ORAL	Prescription	Yes	AB	019949	PFIZER
FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET;ORAL	Prescription	No	AB	078423	ANI PHARMS
FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET;ORAL	Prescription	No	AB	077731	AUROBINDO PHARMA
FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET;ORAL	Prescription	No	AB	076665	CHARTWELL
FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET;ORAL	Prescription	No	AB	076658	DR REDDYS LABS INC
FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET;ORAL	Prescription	No	AB	077253	GLENMARK GENERICS
FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET;ORAL	Prescription	No	AB	076077	IVAX SUB TEVA PHARMS
FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET;ORAL	Prescription	No	AB	076507	TARO
FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET;ORAL	Prescription	No	AB	076957	THINQ PHARM-CRO PVT
FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET;ORAL	Prescription	No	AB	208963	ZYDUS PHARMS

TABLET;ORAL; 150MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIFLUCAN	FLUCONAZOLE	150MG	TABLET;ORAL	Prescription	Yes	AB	019949	PFIZER
FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET;ORAL	Prescription	No	AB	078423	ANI PHARMS
FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET;ORAL	Prescription	No	AB	077731	AUROBINDO PHARMA
FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET;ORAL	Prescription	No	AB	076665	CHARTWELL
FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET;ORAL	Prescription	No	AB	076658	DR REDDYS LABS INC
FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET;ORAL	Prescription	No	AB	077253	GLENMARK GENERICS
FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET;ORAL	Prescription	No	AB	076077	IVAX SUB TEVA PHARMS
FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET;ORAL	Prescription	No	AB	076507	TARO
FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET;ORAL	Prescription	No	AB	076957	THINQ PHARM-CRO PVT
FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET;ORAL	Prescription	No	AB	208963	ZYDUS PHARMS

TABLET;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIFLUCAN	FLUCONAZOLE	200MG	TABLET;ORAL	Prescription	Yes	AB	019949	PFIZER
FLUCONAZOLE	FLUCONAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	078423	ANI PHARMS
FLUCONAZOLE	FLUCONAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	077731	AUROBINDO PHARMA
FLUCONAZOLE	FLUCONAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	076665	CHARTWELL
FLUCONAZOLE	FLUCONAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	076658	DR REDDYS LABS INC
FLUCONAZOLE	FLUCONAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	077253	GLENMARK GENERICS
FLUCONAZOLE	FLUCONAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	076077	IVAX SUB TEVA PHARMS
FLUCONAZOLE	FLUCONAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	076507	TARO
FLUCONAZOLE	FLUCONAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	076957	THINQ PHARM-CRO PVT
FLUCONAZOLE	FLUCONAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	208963	ZYDUS PHARMS

Top