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Drugs@FDA: FDA-Approved Drugs

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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-Container/Carton Labels, Labeling-Package Insert		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 PHARMS LTD
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 PHARMS LTD
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 PHARMS LTD
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 PHARMS LTD
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

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