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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076617
Company: HOSPIRA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FLUCONAZOLE 200MG/100ML (2MG/ML) INJECTABLE;INJECTION Discontinued None No No
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FLUCONAZOLE 400MG/200ML (2MG/ML) INJECTABLE;INJECTION 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
10/30/2003 ORIG-1 Tentative Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76617ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076617_ORIGINAL APPROVAL_PACKAGE.pdf
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