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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074681
Company: TEVA
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
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
04/09/2021 SUPPL-11 Labeling-Package Insert, Labeling-Patient 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.

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