ALKINDI SPRINKLE (nda213876)- (0.5MG,1MG,2MG,5MG)

Generic Name	HYDROCORTISONE	Innovator	ETON
Dosage	0.5MG,1MG,2MG,5MG
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2034-May-12	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ALKINDI SPRINKLE is a corticosteroid indicated as replacement therapy in pediatric patients with adrenocortical insufficiency.

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
0.5MG	**	**	-	-	-
1MG	**	**	-	-	-
2MG	**	**	-	-	-
5MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of ALKINDI SPRINKLE