LYSTEDA (nda022430)- (650MG)

Generic Name	TRANEXAMIC ACID	Innovator	AMRING PHARMS
Dosage	650MG
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2025-Mar-04	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	LYSTEDA is an antifibrinolytic indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
3	0	3

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
650MG	**	**	-	-	3

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	2

Manufacturing Details of LYSTEDA