NDA 21137, held by Genus Lifesciences. Levothyroxine Sodium.
As of Nov 15, 2026, NDA 21137 (Levolet), held by Genus Lifesciences, was first approved by FDA on Jun 6, 2003, with 4 approved supplements and 0 published complete response letters.
| Aug 5, 2022 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Dec 17, 2021 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Dec 17, 2021 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Dec 17, 2021 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Jun 6, 2003 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Levolet0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levolet0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levolet0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levolet0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levolet0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levolet0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levolet0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levolet0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levolet0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levolet0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levolet0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levolet0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
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
