APLENZIN (nda022108)- (174MG,348MG,522MG)

Generic Name	BUPROPION HYDROBROMIDE	Innovator	BAUSCH
Dosage	174MG,348MG,522MG
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2026-Jun-27	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	APLENZIN is an aminoketone antidepressant indicated for the treatment of: Major depressive disorder

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	1	0

Other Developers

Total Other Developers	7

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
174MG	**	**	Up	-	-
348MG	**	**	Up	-	-
522MG	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of APLENZIN