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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019779
Company: HARROW EYE

Products on NDA 019779

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IOPIDINE	APRACLONIDINE HYDROCHLORIDE	EQ 1% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019779

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/31/1987	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/01/2018	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019779s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019779Orig1s025ltr.pdf
04/06/2017	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019779s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019779Orig1s023ltr.pdf
11/05/2015	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
12/15/2004	SUPPL-19	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19779s018,019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19779s018,019ltr.pdf
12/15/2004	SUPPL-18	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19779s018,019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19779s018,019ltr.pdf
05/15/2003	SUPPL-15	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19779SLR015ltr.pdf
03/22/2002	SUPPL-14	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19779S14lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19779s14ltr.pdf
09/21/2001	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
09/13/2000	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
11/03/1997	SUPPL-11	Labeling		Label is not available on this site.
08/27/1996	SUPPL-10	Labeling		Label is not available on this site.
08/30/1995	SUPPL-9	Labeling		Label is not available on this site.
08/20/1992	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
11/29/1990	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
05/02/1990	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
12/15/1989	SUPPL-4	Efficacy-New Indication		Label is not available on this site.
12/11/1989	SUPPL-3	Labeling		Label is not available on this site.
01/03/1989	SUPPL-2	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
03/31/1989	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 019779

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/01/2018	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019779s025lbl.pdf
04/06/2017	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019779s023lbl.pdf
12/15/2004	SUPPL-19	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19779s018,019lbl.pdf
12/15/2004	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19779s018,019lbl.pdf
03/22/2002	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19779S14lbl.pdf

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