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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 201923
Company: ALIMERA SCIENCES INC

Products on NDA 201923

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ILUVIEN	FLUOCINOLONE ACETONIDE	0.19MG	IMPLANT;INTRAVITREAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 201923

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/26/2014	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201923s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201923Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/201923Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/12/2025	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/201923s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/201923Orig1s006ltr.pdf
03/08/2017	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201923s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201923Orig1s002ltr.pdf
05/18/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 201923

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/12/2025	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/201923s006lbl.pdf
03/08/2017	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201923s002lbl.pdf
09/26/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201923s000lbl.pdf

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