TAMBOCOR (nda018830)- (50MG,100MG,150MG,200MG)

Generic Name	FLECAINIDE ACETATE	Innovator	ALVOGEN
Dosage	50MG,100MG,150MG,200MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2004-Feb-10	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	TAMBOCOR tablets, is indicated in patients without structural heart disease, flecainide acetate tablets, USP are indicated for the prevention of — paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms — paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms TAMBOCOR tablets, USP are also indicated for the prevention of — documented ventricular arrhythmias, such as sustained ventricular tachycardia (sustained VT), that in the judgment of the physician are life-threatening.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
7	0	6

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
50MG	**	**	-	-	6
100MG	**	**	-	-	6
150MG	**	**	-	-	6
200MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	6

Manufacturing Details of TAMBOCOR