ZITHROMAX (nda050670)- (EQ 250MG BASE)

Generic Name	AZITHROMYCIN	Innovator	PFIZER
Dosage	EQ 250MG BASE
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ZITHROMAX is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria:  Acute bacterial exacerbations of chronic bronchitis in adults  Acute bacterial sinusitis in adults  Uncomplicated skin and skin structure infections in adults  Urethritis and cervicitis in adults  Genital ulcer disease in men  Acute otitis media in pediatric patients (6 months of age and older)  Community-acquired pneumonia in adults and pediatric patients (6 months of age and older)  Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older)

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 250MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of ZITHROMAX