Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074681
Company: TEVA

Products on ANDA 074681

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET;ORAL	Discontinued	None	No	No
FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET;ORAL	Discontinued	None	No	No
FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET;ORAL	Discontinued	None	No	No
FLUCONAZOLE	FLUCONAZOLE	200MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074681

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/2004/74681ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/15/2022	SUPPL-12	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
04/09/2021	SUPPL-11	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
04/09/2021	SUPPL-10	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
04/09/2021	SUPPL-9	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
04/10/2008	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
02/06/2008	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
02/06/2008	SUPPL-6	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
02/06/2008	SUPPL-4	Manufacturing (CMC)-Facility		Label is not available on this site.
08/29/2006	SUPPL-2	Labeling		Label is not available on this site.