Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077253
Company: GLENMARK PHARMS LTD

Products on ANDA 077253

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 077253

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/25/2006	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
10/24/2023	SUPPL-25	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
07/20/2023	SUPPL-24	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
07/20/2023	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
07/06/2022	SUPPL-21	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
07/06/2022	SUPPL-20	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
10/06/2021	SUPPL-18	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
06/28/2019	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
06/28/2019	SUPPL-16	Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
06/28/2019	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
03/14/2015	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
03/14/2015	SUPPL-9	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.
12/16/2011	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
10/13/2011	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
08/28/2008	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077253

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