CYSTADROPS (nda211302)- (EQ 0.37% BASE)

Generic Name	CYSTEAMINE HYDROCHLORIDE	Innovator	RECORDATI RARE
Dosage	EQ 0.37% BASE
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2023-Aug-19
GAIN Expiry	None	Drug Complexity	No
Indication	CYSTADROPS is a cystine-depleting agent indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis.

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 0.37% BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of CYSTADROPS