Details for New Drug Application (NDA): 021537

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NDA 021537 describes CIPRODEX, which is a drug marketed by Sandoz and is included in one NDA. It is available from three suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the CIPRODEX profile page.

The generic ingredient in CIPRODEX is ciprofloxacin; dexamethasone. There are thirty-four drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.

Summary for 021537

Tradename:	CIPRODEX
Applicant:	Sandoz
Ingredient:	ciprofloxacin; dexamethasone
Patents:	1

Suppliers and Packaging for NDA: 021537

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CIPRODEX	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	021537	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-6186	0781-6186-67	1 BOTTLE, DROPPER in 1 CARTON (0781-6186-67) / 7.5 mL in 1 BOTTLE, DROPPER
CIPRODEX	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	021537	NDA AUTHORIZED GENERIC	Bryant Ranch Prepack	63629-8797	63629-8797-1	1 BOTTLE, DROPPER in 1 CARTON (63629-8797-1) / 7.5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION/DROPS;OTIC			Strength	0.3%;0.1%
Approval Date:	Jul 18, 2003	TE:	AB	RLD:	Yes
Patent:	8,846,650	Patent Expiration:	Jun 4, 2025	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ACUTE OTITIS MEDIA

Expired US Patents for NDA 021537

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	CIPRODEX	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	021537-001	Jul 18, 2003	9,402,805	⤷ Get Started Free
Sandoz	CIPRODEX	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	021537-001	Jul 18, 2003	4,844,902	⤷ Get Started Free
Sandoz	CIPRODEX	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	021537-001	Jul 18, 2003	9,345,714	⤷ Get Started Free
Sandoz	CIPRODEX	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	021537-001	Jul 18, 2003	8,846,650	⤷ Get Started Free
Sandoz	CIPRODEX	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	021537-001	Jul 18, 2003	9,149,486	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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