ADDERALL XR 5 (nda021303)- (1.25MG;1.25MG;1.25MG;1.25MG)

Generic Name	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	Innovator	TAKEDA PHARMS USA
Dosage	1.25MG;1.25MG;1.25MG;1.25MG
ParaIV Filing	Yes	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

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
10	0	10

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	**	**	-	-	10

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	10

Manufacturing Details of ADDERALL XR 5