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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017468
Company: HARROW EYE

Products on NDA 017468

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ECONOPRED	PREDNISOLONE ACETATE	0.125%	SUSPENSION/DROPS;OPHTHALMIC	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017468

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/10/1973	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	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
04/17/2003	SUPPL-19	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17468slr019,17469slr031_econopred_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17468slr019,17469slr031ltr.pdf
08/17/1999	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
04/07/1999	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
08/04/1998	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
03/18/1996	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
11/01/1995	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
11/01/1995	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
06/13/1995	SUPPL-12	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/22/1991	SUPPL-11	Labeling		Label is not available on this site.
03/02/1988	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
03/12/1986	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
03/06/1989	SUPPL-8	Labeling		Label is not available on this site.
05/25/1982	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
05/24/1979	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
04/06/1977	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
05/20/1977	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 017468

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/17/2003	SUPPL-19	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17468slr019,17469slr031_econopred_lbl.pdf

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