Prevents various types of euthyroid goiters (see WARNINGS and PRECAUTIONS ), including…. NDA 21210, held by Stevens J. Levothyroxine Sodium.
As of Nov 14, 2026, NDA 21210 (Unithroid), held by Stevens J, was first approved by FDA on Aug 21, 2000, with 7 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Levothyroxine sodium is used for the following indications: Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter.
| Dec 13, 2004 | Supplement 3Efficacy (new indication or use) | Approved | |
| Jun 23, 2004 | Supplement 2Efficacy (new indication or use) | Approved | |
| Aug 21, 2000 | Original applicationTYPE 7 · Standard review | Approved |
| Unithroid0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | RxReference drug |
| Unithroid0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | RxReference drug |
| Unithroid0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | RxReference drug |
| Unithroid0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | RxReference drug |
| Unithroid0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | RxReference drug |
| Unithroid0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | RxReference drug |
| Unithroid0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | RxReference drug |
| Unithroid0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | RxReference drug |
| Unithroid0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | RxReference drug |
| Unithroid0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | RxReference drug |
| Unithroid0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | RxReference drug |
| Unithroid0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | RxReference drug |
| Dec 10, 2018 | Supplement 8Labeling · Standard review | Approved | |
| Sep 9, 2014 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Sep 1, 2009 | Supplement 6Manufacturing · Standard review | Approved | |
| Feb 8, 2008 | Supplement 4Manufacturing | Approved | |
| Dec 13, 2004 | Supplement 3Efficacy (new indication or use) | Approved | |
| Jun 23, 2004 | Supplement 2Efficacy (new indication or use) | Approved | |
| Dec 15, 2000 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Aug 21, 2000 | Original applicationTYPE 7 · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
