TRUDHESA (nda213436)- (0.725MG/SPRAY)

Generic Name	DIHYDROERGOTAMINE MESYLATE	Innovator	IMPEL PHARMS
Dosage	0.725MG/SPRAY
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2039-Jan-04	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2024-Sep-02
GAIN Expiry	None	Drug Complexity	No
Indication	TRUDHESA is an ergotamine derivative indicated for the acute treatment of migraine with or without aura in adults.

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
0.725MG/SPRAY	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of TRUDHESA