Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020258
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IOPIDINE APRACLONIDINE HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription AT 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
07/30/1993 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

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-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020258s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020258 Orig1s030ltr.pdf
04/06/2017 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020258s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020258Orig1s026ltr.pdf
05/09/2003 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20258slr019_iopidine_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20258slr019ltr.pdf
12/04/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/2002 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

09/21/2001 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/2000 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

02/18/2000 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/17/1999 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/2000 SUPPL-11 Labeling

Label is not available on this site.

09/28/1999 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

04/07/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/05/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/11/1999 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/04/1998 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

01/15/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/09/1997 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/17/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/01/1995 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1995 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/01/2018 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020258s030lbl.pdf
04/06/2017 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020258s026lbl.pdf
05/09/2003 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20258slr019_iopidine_lbl.pdf

IOPIDINE

SOLUTION/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
APRACLONIDINE HYDROCHLORIDE APRACLONIDINE HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 077764 AKORN INC
IOPIDINE APRACLONIDINE HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 020258 NOVARTIS

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