SDAMLO (NDA219531)- (EQ 2.5MG BASE/BOT,EQ 5MG BASE/BOT,EQ 10MG BASE/BOT)

Generic Name	AMLODIPINE BESYLATE	Innovator	BRILLIAN PHARMA
Dosage	EQ 2.5MG BASE/BOT,EQ 5MG BASE/BOT,EQ 10MG BASE/BOT
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Sdamlo is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: • Hypertension • Sdamlo is indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients 6 years of age and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. • Coronary Artery Disease in adults • Chronic Stable Angina • Vasospastic Angina (Prinzmetal's or Variant Angina) • Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

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
EQ 2.5MG BASE/BOT	**	**	-	-	-
EQ 5MG BASE/BOT	**	**	-	-	-
EQ 10MG BASE/BOT	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of SDAMLO