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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208963
Company: ZYDUS PHARMS

Products on ANDA 208963

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 208963

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/16/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/15/2024	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
01/23/2024	SUPPL-15	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
01/23/2024	SUPPL-13	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
06/09/2022	SUPPL-11	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
06/09/2022	SUPPL-10	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
10/06/2021	SUPPL-9	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
07/16/2019	SUPPL-5	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
07/16/2019	SUPPL-3	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
07/16/2019	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
07/16/2019	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208963

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; 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

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

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