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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022186
Company: LONG GROVE PHARMS

Summary Review

Products on NDA 022186

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	Yes
AK-FLUOR 25%	FLUORESCEIN SODIUM	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE;INTRAVENOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022186

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
02/28/2025	SUPPL-13	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022186Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022186Orig1s013ltr.pdf
07/20/2015	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022186

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2025	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022186Orig1s013lbl.pdf
02/28/2025	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022186Orig1s013lbl.pdf

Therapeutic Equivalents for NDA 022186

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	LONG GROVE PHARMS
FLUORESCEIN SODIUM	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	215709	NEXUS
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.

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