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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022315
Company: ABBVIE

Summary Review

Products on NDA 022315

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OZURDEX	DEXAMETHASONE	0.7MG	IMPLANT;INTRAVITREAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022315

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/17/2009	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022315lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022315s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022315_ozurdex_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022315s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/19/2022	SUPPL-16	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022315Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022315Orig1s016ltr.pdf
10/21/2020	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022315s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022315Orig1s013ltr.pdf
05/15/2018	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022315s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022315Orig1s012ltr.pdf
02/05/2016	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
09/26/2014	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022315s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022315Orig1s010ltr.pdf
06/28/2014	SUPPL-9	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022315s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022315Orig1s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022315Orig1s009.pdf
02/07/2014	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022315s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022315Orig1s008ltr.pdf
09/07/2012	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022315s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022315Orig1s007ltr.pdf
02/24/2012	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022315s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022315s005ltr.pdf
09/24/2010	SUPPL-3	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022315s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022315s003ltr.pdf
08/31/2010	SUPPL-2	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022315s002ltr.pdf

Labels for NDA 022315

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/19/2022	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022315Orig1s016lbl.pdf
12/19/2022	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022315Orig1s016lbl.pdf
10/21/2020	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022315s013lbl.pdf
05/15/2018	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022315s012lbl.pdf
09/26/2014	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022315s010lbl.pdf
06/28/2014	SUPPL-9	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022315s009lbl.pdf
02/07/2014	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022315s008lbl.pdf
09/07/2012	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022315s007lbl.pdf
02/24/2012	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022315s005lbl.pdf
09/24/2010	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022315s003lbl.pdf
06/17/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022315lbl.pdf

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