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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020369
Company: SANDOZ

Products on NDA 020369

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020369

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-Container/Carton Labels, Labeling-Package Insert	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.

Labels for NDA 020369

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/17/2017	SUPPL-22	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020369s022lbl.pdf
02/17/2017	SUPPL-22	Labeling-Package Insert	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

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