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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 013422
Company: HARROW EYE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MAXIDEX DEXAMETHASONE 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
06/20/1962 ORIG-1 Approval Type 3 - New Dosage Form 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
12/10/2021 SUPPL-49 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/013422s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/013422Orig1s049ltr.pdf
05/14/2021 SUPPL-46 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/013422s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/013422Orig1s046ltr.pdf
11/03/2017 SUPPL-45 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/013422s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/013422Orig1s045ltr.pdf
08/05/2016 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.
03/10/2016 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.
04/07/2015 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.
09/27/2013 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.
04/17/2003 SUPPL-35 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/13422slr035_maxidex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/13422slr035ltr.pdf
12/11/2002 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.
12/04/2002 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.
02/04/2000 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.
08/17/1999 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.
04/07/1999 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.
02/05/1999 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.
03/11/1999 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.
08/04/1998 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.
10/17/1996 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.
09/26/1996 SUPPL-24 Labeling

Label is not available on this site.
03/18/1996 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.
11/01/1995 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.
11/01/1995 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.
06/14/1995 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.
11/28/1989 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.
12/06/1989 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
03/02/1988 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
03/21/1984 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.
08/05/1983 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
08/08/1984 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.
08/05/1981 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.
07/06/1979 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.
07/06/1979 SUPPL-10 Labeling

Label is not available on this site.
05/31/1990 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/10/2021 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/013422s049lbl.pdf
05/14/2021 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/013422s046lbl.pdf
11/03/2017 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/013422s045lbl.pdf
04/17/2003 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/13422slr035_maxidex_lbl.pdf
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