TIROSINT-SOL (nda206977)- (13MCG/ML,25MCG/ML,37.5MCG/ML,44MCG/ML,50MCG/ML,62.5MCG/ML,75MCG/ML,88MCG/ML,100MCG/ML,112MCG/ML,125MCG/ML,137MCG/ML,150MCG/ML,175MCG/ML,200MCG/ML)

Generic Name	LEVOTHYROXINE SODIUM	Innovator	IBSA
Dosage	13MCG/ML,25MCG/ML,37.5MCG/ML,44MCG/ML,50MCG/ML,62.5MCG/ML,75MCG/ML,88MCG/ML,100MCG/ML,112MCG/ML,125MCG/ML,137MCG/ML,150MCG/ML,175MCG/ML,200MCG/ML
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2039-Sep-17	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	TIROSINT- SOL is L-thyroxine (T4) indicated for: • Hypothyroidism -As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism • Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer

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
13MCG/ML	**	**	-	-	-
25MCG/ML	**	**	-	-	-
37.5MCG/ML	**	**	-	-	-
44MCG/ML	**	**	-	-	-
50MCG/ML	**	**	-	-	-
62.5MCG/ML	**	**	-	-	-
75MCG/ML	**	**	-	-	-
88MCG/ML	**	**	-	-	-
100MCG/ML	**	**	-	-	-
112MCG/ML	**	**	-	-	-
125MCG/ML	**	**	-	-	-
137MCG/ML	**	**	-	-	-
150MCG/ML	**	**	-	-	-
175MCG/ML	**	**	-	-	-
200MCG/ML	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of TIROSINT-SOL