ADDERALL 5 (nda011522)- (1.25MG;1.25MG;1.25MG;1.25MG)

Generic Name	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	Innovator	TEVA WOMENS
Dosage	1.25MG;1.25MG;1.25MG;1.25MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2021-Jan-06	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ADDERALL® is indicated in Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
19	0	14

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
1.25MG;1.25MG;1.25MG;1.25MG	**	**	-	1	12

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	14

Manufacturing Details of ADDERALL 5