Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076918
Company: TARO PHARM INDS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUCONAZOLE FLUCONAZOLE 50MG/5ML FOR SUSPENSION;ORAL Discontinued None No No
FLUCONAZOLE FLUCONAZOLE 200MG/5ML FOR SUSPENSION;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
12/18/2006 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/27/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

08/27/2015 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

08/27/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

04/18/2012 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

01/25/2012 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

11/06/2008 SUPPL-1 Labeling

Label is not available on this site.

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