MYDAYIS (nda022063)- (3.125MG;3.125MG;3.125MG;3.125MG,6.25MG;6.25MG;6.25MG;6.25MG,9.375MG;9.375MG;9.375MG;9.375MG,12.5MG;12.5MG;12.5MG;12.5MG)

Generic Name	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	Innovator	TAKEDA PHARMS USA
Dosage	3.125MG;3.125MG;3.125MG;3.125MG,6.25MG;6.25MG;6.25MG;6.25MG,9.375MG;9.375MG;9.375MG;9.375MG,12.5MG;12.5MG;12.5MG;12.5MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2029-Aug-24	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
3	0	3

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
3.125MG;3.125MG;3.125MG;3.125MG	**	**	-	-	2
6.25MG;6.25MG;6.25MG;6.25MG	**	**	-	-	3
9.375MG;9.375MG;9.375MG;9.375MG	**	**	-	-	3
12.5MG;12.5MG;12.5MG;12.5MG	**	**	-	-	3

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	2

Manufacturing Details of MYDAYIS