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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076246
Company: HIKMA
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
07/29/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76246ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/19/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

03/19/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

03/19/2015 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

01/25/2012 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

01/25/2012 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

01/25/2012 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

01/07/2009 SUPPL-6 Labeling

Label is not available on this site.

12/06/2005 SUPPL-2 Labeling

Label is not available on this site.

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