Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021537
Company: NOVARTIS PHARMS CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CIPRODEX CIPROFLOXACIN; DEXAMETHASONE 0.3%;0.1% SUSPENSION/DROPS;OTIC 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
07/18/2003 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21537ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021537_Ciprodex.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/21/2019 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021537s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021537Orig1s017ltr.pdf
12/10/2015 SUPPL-12 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021537s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021537Orig1s012ltr.pdf
05/22/2013 SUPPL-8 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021537Orig1s008.pdf
03/01/2004 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
02/21/2019 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021537s017lbl.pdf
12/10/2015 SUPPL-12 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021537s012lbl.pdf

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