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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021537
Company: SANDOZ

Products on NDA 021537

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	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021537

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 (PDF)	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/2026/21537Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/27/2022	SUPPL-19	Manufacturing (CMC)-Facility	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/021537Orig1s019.pdf
11/03/2020	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021537s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021537Orig1s018ltr.pdf
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.

Labels for NDA 021537

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/03/2020	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021537s018lbl.pdf
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

Therapeutic Equivalents for NDA 021537

CIPRODEX

SUSPENSION/DROPS;OTIC; 0.3%;0.1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CIPRODEX	CIPROFLOXACIN; DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS;OTIC	Prescription	Yes	AB	021537	SANDOZ
CIPROFLOXACIN AND DEXAMETHASONE	CIPROFLOXACIN; DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS;OTIC	Prescription	No	AB	216501	AMNEAL
CIPROFLOXACIN AND DEXAMETHASONE	CIPROFLOXACIN; DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS;OTIC	Prescription	No	AB	205548	DR REDDYS
CIPROFLOXACIN AND DEXAMETHASONE	CIPROFLOXACIN; DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS;OTIC	Prescription	No	AB	215768	SENTISS
CIPROFLOXACIN AND DEXAMETHASONE	CIPROFLOXACIN; DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS;OTIC	Prescription	No	AB	210470	SUN PHARM
CIPROFLOXACIN AND DEXAMETHASONE	CIPROFLOXACIN; DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS;OTIC	Prescription	No	AB	216487	UPSHER SMITH LABS

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