MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) (nda216359)- (EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML))

Generic Name	MIDAZOLAM HYDROCHLORIDE	Innovator	RAFA LABS LTD
Dosage	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Midazolam Injection is a benzodiazepine indicated for the treatment of status epilepticus 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 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)