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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021862
Company: HARROW EYE

Products on NDA 021862

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NEVANAC	NEPAFENAC	0.1%	SUSPENSION/DROPS;OPHTHALMIC	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021862

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/19/2005	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021862lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021862ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021862s000_NevanacTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/04/2020	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021862s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021862Orig1s017ltr.pdf
12/15/2017	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021862s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021862Orig1s013ltr.pdf
03/07/2014	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
06/27/2011	SUPPL-8	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021862s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021862s008ltr.pdf
05/08/2008	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021862s002lbl.pdf

Labels for NDA 021862

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/04/2020	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021862s017lbl.pdf
12/15/2017	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021862s013lbl.pdf
06/27/2011	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021862s008lbl.pdf
06/27/2011	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021862s008lbl.pdf
05/08/2008	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021862s002lbl.pdf
08/19/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021862lbl.pdf

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