QUZYTTIR (nda211415)- (10MG/ML (10MG/ML))

Generic Name	CETIRIZINE HYDROCHLORIDE	Innovator	JDP
Dosage	10MG/ML (10MG/ML)
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2030-Feb-28	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2022-Oct-04
GAIN Expiry	None	Drug Complexity	No
Indication	QUZYTTIRTMis a histamine-1 (H1) receptor antagonist indicated for the treatment of acute urticaria in adults and children 6 months of age and older.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
10MG/ML (10MG/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of QUZYTTIR