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UNITHROID (nda021210)- (0.025MG,0.025MG,0.025MG,0.05MG,0.05MG,0.05MG,0.075MG,0.075MG,0.075MG,0.088MG,0.088MG,0.088MG,0.1MG,0.1MG,0.1MG,0.112MG,0.112MG,0.112MG,0.125MG,0.125MG,0.125MG,0.137MG,0.137MG,0.137MG,0.15MG,0.15MG,0.15MG,0.175MG,0.175MG,0.175MG,0.2MG,0.2MG,0.2MG,0.3MG,0.3MG,0.3MG)

LEVOTHYROXINE SODIUM STEVENS J
0.025MG,0.025MG,0.025MG,0.05MG,0.05MG,0.05MG,0.075MG,0.075MG,0.075MG,0.088MG,0.088MG,0.088MG,0.1MG,0.1MG,0.1MG,0.112MG,0.112MG,0.112MG,0.125MG,0.125MG,0.125MG,0.137MG,0.137MG,0.137MG,0.15MG,0.15MG,0.15MG,0.175MG,0.175MG,0.175MG,0.2MG,0.2MG,0.2MG,0.3MG,0.3MG,0.3MG
No Yes
Expired Expired
None None
None No
UNITHROID is L-thyroxine (T4) indicated in pediatric and adult patients for: • Hypothyroidism: As replacement 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.
5 0 1
Total Other Developers 20
Drugs with Suitability No
0.025MG ** ** Down - 3
0.05MG ** ** - - 1
0.075MG ** ** Up - 3
0.088MG ** ** Up - 3
0.1MG ** ** Up - 3
0.112MG ** ** - - 1
0.125MG ** ** - - 3
0.137MG ** ** - - 3
0.15MG ** ** Up - 3
0.175MG ** ** - - 1
0.2MG ** ** - - -
0.3MG ** ** Down - 1
NDA Sales Available Total Generic Sales Available
Yes 1
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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