Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020369
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CILOXAN CIPROFLOXACIN HYDROCHLORIDE EQ 0.3% BASE OINTMENT;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
03/30/1998 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20369lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20369ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020369_ciloxan.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/17/2017 SUPPL-22 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020369s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020369Orig1s022ltr.pdf
08/05/2016 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

09/09/2015 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/15/2004 SUPPL-10 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20369s009,010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20369s009,010ltr.pdf
07/15/2004 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20369s009,010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20369s009,010ltr.pdf
08/19/2003 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020369s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20369scm006,slr007ltr.pdf
08/19/2003 SUPPL-6 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020369s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20369scm006,slr007ltr.pdf
12/11/2000 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/07/2000 SUPPL-4 Labeling

Label is not available on this site.

09/28/1999 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/07/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/05/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/17/2017 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020369s022lbl.pdf
02/17/2017 SUPPL-22 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020369s022lbl.pdf
07/15/2004 SUPPL-10 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20369s009,010lbl.pdf
07/15/2004 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20369s009,010lbl.pdf
08/19/2003 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020369s006s007lbl.pdf
08/19/2003 SUPPL-6 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020369s006s007lbl.pdf
03/30/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20369lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English