Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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 ALCON LABS INC

AK-FLUOR 25%

There are no Therapeutic Equivalents.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English