NDA 21402, held by Abbvie. Levothyroxine Sodium.
As of Nov 14, 2026, NDA 21402 (Synthroid), held by Abbvie, was first approved by FDA on Jul 24, 2002, with 13 approved supplements and 0 published complete response letters.
Hypothyroidism SYNTHROID is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid -Stimulating Hormone, TSH) Suppression SYNTHROID is
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 24, 2002 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Synthroid0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | RxReference drug |
| Synthroid0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | RxReference drug |
| Synthroid0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | RxReference drug |
| Synthroid0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | RxReference drug |
| Synthroid0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | RxReference drug |
| Synthroid0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | RxReference drug |
| Synthroid0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | RxReference drug |
| Synthroid0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | RxReference drug |
| Synthroid0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | RxReference drug |
| Synthroid0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | RxReference drug |
| Synthroid0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | RxReference drug |
| Synthroid0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | RxReference drug |
| Feb 20, 2024 | Supplement 38Labeling · Standard review | Approved | |
| Aug 30, 2022 | Supplement 36Labeling · Standard review | Approved | |
| Jul 15, 2020 | Supplement 34Labeling · Standard review | Approved | |
| Feb 23, 2017 | Supplement 28Labeling · Standard review | Approved | |
| Feb 23, 2017 | Supplement 24Labeling · Standard review | Approved | |
| May 13, 2016 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Nov 25, 2015 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Apr 15, 2015 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| May 27, 2014 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Apr 8, 2014 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Jan 14, 2011 | Supplement 20Labeling | Approved | |
| Jul 14, 2008 | Supplement 17Labeling · Standard review | Approved | |
| Apr 20, 2008 | Supplement 11Labeling · Standard review | Approved | |
| Jul 24, 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
