Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021980
Company: NOVARTIS PHARMS CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUORESCITE FLUORESCEIN SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription AP 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
03/28/2006 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021980s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021980s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021980s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/09/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/12/2014 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/02/2016 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021980s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021980Orig1s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/02/2016 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021980s004lbl.pdf
03/28/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021980s000lbl.pdf

FLUORESCITE

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

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