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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208742
Company: OCULAR THERAPEUTIX

Products on NDA 208742

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXTENZA	DEXAMETHASONE	0.4MG	INSERT;OPHTHALMIC	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208742

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/30/2018	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208742Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208742Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/07/2025	SUPPL-13	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208742s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/208742Orig1s013ltr.pdf
10/07/2021	SUPPL-7	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208742s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208742Orig1s007ltr.pdf
03/02/2020	SUPPL-5	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208742Orig1s005ltr.pdf
06/20/2019	SUPPL-1	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208742s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208742Orig1s001ltr.pdf

Labels for NDA 208742

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/07/2025	SUPPL-13	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208742s013lbl.pdf
10/07/2021	SUPPL-7	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208742s007lbl.pdf
06/20/2019	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208742s001lbl.pdf

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