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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076077
Company: IVAX SUB TEVA PHARMS

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/2004/76077ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/24/2023 SUPPL-21 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
10/24/2023 SUPPL-20 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.
10/24/2023 SUPPL-19 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
10/06/2021 SUPPL-18 Labeling-Package Insert

Label is not available on this site.
07/16/2019 SUPPL-16 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
07/16/2019 SUPPL-15 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.
07/16/2019 SUPPL-14 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
07/16/2019 SUPPL-13 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.
03/18/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.
03/18/2015 SUPPL-10 Labeling-Package Insert

Label is not available on this site.
01/23/2012 SUPPL-6 Labeling-Package Insert

Label is not available on this site.
01/23/2012 SUPPL-5 Labeling-Package Insert

Label is not available on this site.
12/27/2010 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
06/27/2008 SUPPL-2 Labeling

Label is not available on this site.
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