THYRO-TABS (nda021116)- (0.025MG,0.025MG,0.025MG,0.025MG,0.05MG,0.05MG,0.05MG,0.05MG,0.075MG,0.075MG,0.075MG,0.075MG,0.088MG,0.088MG,0.088MG,0.088MG,0.1MG,0.1MG,0.1MG,0.1MG,0.112MG,0.112MG,0.112MG,0.112MG,0.125MG,0.125MG,0.125MG,0.125MG,0.137MG,0.137MG,0.137MG,0.137MG,0.15MG,0.15MG,0.15MG,0.15MG,0.175MG,0.175MG,0.175MG,0.175MG,0.2MG,0.2MG,0.2MG,0.2MG,0.3MG,0.3MG,0.3MG,0.3MG)

Generic Name	LEVOTHYROXINE SODIUM	Innovator	ALVOGEN
Dosage	0.025MG,0.025MG,0.025MG,0.025MG,0.05MG,0.05MG,0.05MG,0.05MG,0.075MG,0.075MG,0.075MG,0.075MG,0.088MG,0.088MG,0.088MG,0.088MG,0.1MG,0.1MG,0.1MG,0.1MG,0.112MG,0.112MG,0.112MG,0.112MG,0.125MG,0.125MG,0.125MG,0.125MG,0.137MG,0.137MG,0.137MG,0.137MG,0.15MG,0.15MG,0.15MG,0.15MG,0.175MG,0.175MG,0.175MG,0.175MG,0.2MG,0.2MG,0.2MG,0.2MG,0.3MG,0.3MG,0.3MG,0.3MG
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Levothyroxine Sodium Tablets are 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
4	0	2

Other Developers

Total Other Developers	3

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.025MG	**	**	-	-	-
0.05MG	**	**	-	-	-
0.075MG	**	**	-	-	-
0.088MG	**	**	-	-	-
0.1MG	**	**	-	-	-
0.112MG	**	**	-	-	-
0.125MG	**	**	Down	-	-
0.137MG	**	**	-	-	-
0.15MG	**	**	-	-	-
0.175MG	**	**	-	-	-
0.2MG	**	**	-	-	-
0.3MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of THYRO-TABS