Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076213
Company: ROXANE
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/2004/76213ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/06/2005 SUPPL-2 Labeling

Label is not available on this site.

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