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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076957
Company: UNIQUE

Products on ANDA 076957

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	200MG	TABLET;ORAL	Prescription	AB	No	No
FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076957

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/28/2005	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/26/2024	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
10/24/2023	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
10/24/2023	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
07/12/2022	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
07/12/2022	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
07/12/2022	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
06/22/2020	SUPPL-8	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
06/22/2020	SUPPL-6	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
06/22/2020	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
02/02/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
01/09/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076957

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	218692	FDC LTD
FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET;ORAL	Prescription	No	AB	077253	GLENMARK PHARMS LTD
FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET;ORAL	Prescription	No	AB	076957	UNIQUE
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	218692	FDC LTD
FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET;ORAL	Prescription	No	AB	077253	GLENMARK PHARMS LTD
FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET;ORAL	Prescription	No	AB	076957	UNIQUE
FLUCONAZOLE	FLUCONAZOLE	100MG	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	218692	FDC LTD
FLUCONAZOLE	FLUCONAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	077253	GLENMARK PHARMS LTD
FLUCONAZOLE	FLUCONAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	076957	UNIQUE
FLUCONAZOLE	FLUCONAZOLE	200MG	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	218692	FDC LTD
FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET;ORAL	Prescription	No	AB	077253	GLENMARK PHARMS LTD
FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET;ORAL	Prescription	No	AB	076957	UNIQUE
FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET;ORAL	Prescription	No	AB	208963	ZYDUS PHARMS

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