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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019992
Company: SANDOZ

Products on NDA 019992

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CILOXAN	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019992

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/31/1990	ORIG-1	Approval	Type 3 - New Dosage Form	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
03/21/2017	SUPPL-26	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019992s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019992Orig1s026ltr.pdf
02/07/2006	SUPPL-20	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019992s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019992s020ltr.pdf
08/20/2004	SUPPL-19	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19992s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19992s019ltr.pdf
03/13/2002	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
09/14/2001	SUPPL-15	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/16/2001	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.
02/05/1999	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
03/11/1999	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
10/14/1998	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
11/09/1999	SUPPL-8	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/15/1998	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
11/01/1995	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
11/01/1995	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
10/27/1994	SUPPL-4	Efficacy-New Patient Population		Label is not available on this site.
01/22/1993	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
10/27/1993	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/12/1992	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 019992

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/21/2017	SUPPL-26	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019992s026lbl.pdf
03/21/2017	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019992s026lbl.pdf
02/07/2006	SUPPL-20	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019992s020lbl.pdf
08/20/2004	SUPPL-19	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19992s019lbl.pdf

Therapeutic Equivalents for NDA 019992

CILOXAN

SOLUTION/DROPS;OPHTHALMIC; EQ 0.3% BASE
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CILOXAN	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT	019992	SANDOZ
CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	204613	ALTAIRE PHARMS INC
CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	077568	FDC LTD
CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	077689	RISING
CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	075928	RUBICON
CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	076673	WATSON LABS INC

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