SUBLIMAZE PRESERVATIVE FREE (nda016619)- (EQ 0.05MG BASE/ML)

Generic Name	FENTANYL CITRATE	Innovator	RISING
Dosage	EQ 0.05MG BASE/ML
ParaIV Filing	No	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	Fentanyl Citrate Injection is an opioid agonist indicated for: • analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises. • use as an opioid analgesic supplement in general or regional anesthesia. • administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia. • use as an anesthetic agent with oxygen in selected high risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures.

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
EQ 0.05MG BASE/ML	**	**	-	-	1

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	3

Manufacturing Details of SUBLIMAZE PRESERVATIVE FREE