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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021980
Company: ALCON LABS INC

Products on NDA 021980

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021980

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.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/10/2026	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021980s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/021980Orig1s012ltr.pdf
11/17/2021	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021980Orig1s007lbl.pdf
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

Labels for NDA 021980

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/10/2026	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021980s012lbl.pdf
11/17/2021	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021980Orig1s007lbl.pdf
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

Therapeutic Equivalents for NDA 021980

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	LONG GROVE PHARMS
FLUORESCEIN SODIUM	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	220046	BPI LABS
FLUORESCEIN SODIUM	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	215709	NEXUS
FLUORESCEIN SODIUM	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	218651	ZYDUS LIFESCIENCES
FLUORESCITE	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	021980	ALCON LABS INC

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