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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019079
Company: HARROW EYE

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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/11/1986 ORIG-1 Approval Type 2 - New Active Ingredient 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
08/02/2022 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019079s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019079Orig1s033ltr.pdf
10/24/2016 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019079s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019079Orig1s030ltr.pdf
11/08/2006 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019079s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019079s024LTR.pdf
12/11/2002 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.
12/04/2002 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.
06/10/2002 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.
03/16/2001 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
02/18/2000 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
11/05/1999 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.
08/17/1999 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.
02/05/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
03/11/1999 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.
02/04/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
08/04/1998 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
07/30/1997 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.
04/21/1997 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
09/26/1996 SUPPL-9 Labeling

Label is not available on this site.
07/19/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
03/18/1996 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
11/01/1995 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
11/01/1995 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.
06/13/1995 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/04/1987 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.
12/09/1986 SUPPL-2 Labeling

Label is not available on this site.
03/24/1986 SUPPL-1 Manufacturing (CMC)-Formulation

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
08/02/2022 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019079s033lbl.pdf
10/24/2016 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019079s030lbl.pdf
11/08/2006 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019079s024lbl.pdf
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