Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022186
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AK-FLUOR 10% FLUORESCEIN SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription AP Yes No
AK-FLUOR 25% FLUORESCEIN SODIUM EQ 500MG BASE/2ML (EQ 250MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/08/2008 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Letter (PDF)
Review
Summary Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022186s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022186_akfluor_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022186s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/20/2015 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

AK-FLUOR 10%

INJECTABLE;INTRAVENOUS; EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AK-FLUOR 10% FLUORESCEIN SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription Yes AP 022186 AKORN
FLUORESCITE FLUORESCEIN SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription Yes AP 021980 NOVARTIS PHARMS CORP

AK-FLUOR 25%

There are no Therapeutic Equivalents.

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