CIPRODEX (nda021537)- (0.3%;0.1%)

Generic Name	CIPROFLOXACIN; DEXAMETHASONE	Innovator	SANDOZ
Dosage	0.3%;0.1%
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2025-Jun-04	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	CIPRODEX is a combination of ciprofloxacin, a fluoroquinolone antibacterial and dexamethasone, a corticosteroid, indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: • Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa. • Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult, and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
4	0	4

Other Developers

Total Other Developers	24

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.3%;0.1%	**	**	Up	-	4

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	4

Manufacturing Details of CIPRODEX