SOFDRA (NDA217347)- (12.45%)

Generic Name	SOFPIRONIUM	Innovator	BOTANIX SB INC.
Dosage	12.45%
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2040-May-22	NCE Excl Expiry	2029-Jun-20
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	SOFDRA is an anticholinergic indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older.

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
12.45%	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of SOFDRA