ONTRALFY (NDA216190)- (EQ 2MG BASE/5ML)

Generic Name	TIZANIDINE HYDROCHLORIDE	Innovator	FIDELITY BIOPHARMA
Dosage	EQ 2MG BASE/5ML
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2042-May-07	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Ontralfy is a central alpha-2-adrenergic agonist indicated for the treatment of spasticity 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
EQ 2MG BASE/5ML	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of ONTRALFY