Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019779
Company: NOVARTIS PHARMS CORP
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
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.

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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