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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020805
Company: SANDOZ

Products on NDA 020805

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CIPRO HC	CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE	EQ 0.2% BASE;1%	SUSPENSION/DROPS;OTIC	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020805

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/10/1998	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20805-mr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20805-mr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20805.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/20/2017	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020805s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020805Orig1s011ltr.pdf
07/09/2013	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
03/13/2002	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
04/19/2001	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
02/27/2001	SUPPL-4	Manufacturing (CMC)-Formulation		Label is not available on this site.
10/14/1999	SUPPL-3	Labeling		Label is not available on this site.
09/17/1998	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
09/15/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 020805

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/20/2017	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020805s011lbl.pdf
02/10/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20805-mr.pdf

Therapeutic Equivalents for NDA 020805

CIPRO HC

SUSPENSION/DROPS;OTIC; EQ 0.2% BASE;1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CIPRO HC	CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE	EQ 0.2% BASE;1%	SUSPENSION/DROPS;OTIC	Prescription	Yes	AB	020805	SANDOZ
CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE	CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE	EQ 0.2% BASE;1%	SUSPENSION/DROPS;OTIC	Prescription	No	AB	218273	COSETTE PHARMS NC

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