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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076351
Company: MYLAN
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/2004/76351ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/09/2022 SUPPL-16 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

06/09/2022 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

05/25/2021 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

05/25/2021 SUPPL-12 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

05/25/2021 SUPPL-11 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

05/25/2021 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

01/25/2012 SUPPL-8 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

12/28/2010 SUPPL-7 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

11/17/2009 SUPPL-6 Labeling-Container/Carton Labels

Label is not available on this site.

12/20/2004 SUPPL-1 Labeling

Label is not available on this site.

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