LUPRON DEPOT-PED KIT (nda020263)- (3.75MG,7.5MG,7.5MG,7.5MG,7.5MG,11.25MG,11.25MG,15MG,30MG,45MG)

Generic Name	LEUPROLIDE ACETATE	Innovator	ABBVIE ENDOCRINE INC
Dosage	3.75MG,7.5MG,7.5MG,7.5MG,7.5MG,11.25MG,11.25MG,15MG,30MG,45MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2016-Dec-13	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	LUPRON DEPOT-PED is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients with central precocious puberty.

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
3.75MG,7.5MG	**	**	-	-	-
7.5MG	**	**	-	-	-
7.5MG,7.5MG	**	**	-	-	-
11.25MG	**	**	-	-	-
15MG	**	**	-	-	-
30MG	**	**	-	-	-
45MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of LUPRON DEPOT-PED KIT