Manages thyrotropin-dependent well-differentiated thyroid cancer. NDA 21342, held by Cediprof Inc. Levothyroxine Sodium.
As of Nov 14, 2026, NDA 21342 (Levo-T), held by Cediprof Inc, was first approved by FDA on Mar 1, 2002, with 13 approved supplements and 0 published complete response letters.
Hypothyroidism Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
| Mar 9, 2011 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Jun 23, 2004 | Supplement 3Efficacy (new indication or use) | Approved | |
| Jun 23, 2004 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Mar 1, 2002 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Levo-T0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levo-T0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levo-T0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levo-T0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levo-T0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levo-T0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levo-T0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levo-T0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levo-T0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levo-T0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levo-T0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levo-T0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| May 4, 2026 | Supplement 28Labeling · Standard review | Approved | |
| Dec 5, 2017 | Supplement 23Labeling · Standard review | Approved | |
| Jan 12, 2017 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Feb 9, 2015 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Nov 20, 2012 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Mar 9, 2011 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Jun 14, 2009 | Supplement 16Manufacturing · Standard review | Approved | |
| Jun 10, 2008 | Supplement 8Labeling · Standard review | Approved | |
| Jun 10, 2008 | Supplement 14Labeling · Standard review | Approved | |
| Jun 23, 2004 | Supplement 3Efficacy (new indication or use) | Approved | |
| Jun 23, 2004 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Dec 8, 2003 | Supplement 1Manufacturing · Standard review | Approved | |
| Aug 21, 2003 | Supplement 2Manufacturing · Standard review | Approved | |
| Mar 1, 2002 | Original applicationNew formulation or manufacturer · 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
