NDA 21292, held by Emd Serono Inc. Levothyroxine Sodium.
As of Nov 14, 2026, NDA 21292 (Euthyrox), held by Emd Serono Inc, was first approved by FDA on May 31, 2002, with 5 approved supplements and 0 published complete response letters.
| Sep 14, 2018 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| May 31, 2002 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Euthyrox0.025MG · tablet;oral | Levothyroxine Sodium | Discontinued |
| Euthyrox0.05MG · tablet;oral | Levothyroxine Sodium | Discontinued |
| Euthyrox0.075MG · tablet;oral | Levothyroxine Sodium | Discontinued |
| Euthyrox0.088MG · tablet;oral | Levothyroxine Sodium | Discontinued |
| Euthyrox0.1MG · tablet;oral | Levothyroxine Sodium | Discontinued |
| Euthyrox0.112MG · tablet;oral | Levothyroxine Sodium | Discontinued |
| Euthyrox0.125MG · tablet;oral | Levothyroxine Sodium | Discontinued |
| Euthyrox0.137MG · tablet;oral | Levothyroxine Sodium | Discontinued |
| Euthyrox0.15MG · tablet;oral | Levothyroxine Sodium | Discontinued |
| Euthyrox0.175MG · tablet;oral | Levothyroxine Sodium | Discontinued |
| Euthyrox0.2MG · tablet;oral | Levothyroxine Sodium | Discontinued |
| Euthyrox0.3MG · tablet;oral | Levothyroxine Sodium | Discontinued |
| Apr 27, 2022 | Supplement 10Labeling · Standard review | Approved | |
| Sep 14, 2018 | Supplement 6Labeling · Standard review | Approved | |
| Sep 14, 2018 | Supplement 5Labeling · Standard review | Approved | |
| Sep 14, 2018 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Mar 26, 2009 | Supplement 2Labeling · Standard review | Approved | |
| May 31, 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
