ANDA 76187, held by Mylan. Levothyroxine Sodium.
As of Nov 15, 2026, ANDA 76187 (Levothyroxine Sodium), held by Mylan, was first approved by FDA on Jun 5, 2002, with 12 approved supplements and 0 published complete response letters.
Hypothyroidism Levothyroxine sodium tablets are 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 Levothyroxine sodium tablets are
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 5, 2002 | Original application | Approved |
| Levothyroxine Sodium0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levothyroxine Sodium0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levothyroxine Sodium0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levothyroxine Sodium0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levothyroxine Sodium0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levothyroxine Sodium0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levothyroxine Sodium0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levothyroxine Sodium0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levothyroxine Sodium0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levothyroxine Sodium0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levothyroxine Sodium0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levothyroxine Sodium0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| May 1, 2025 | Supplement 53Labeling · Standard review | Approved | None posted |
| Jul 20, 2023 | Supplement 50Labeling · Standard review | Approved | None posted |
| Nov 5, 2020 | Supplement 38Labeling · Standard review | Approved | None posted |
| Nov 5, 2020 | Supplement 32Labeling · Standard review | Approved | None posted |
| Oct 30, 2014 | Supplement 22Manufacturing | Approved | None posted |
| Oct 9, 2014 | Supplement 28Manufacturing | Approved | None posted |
| Oct 30, 2008 | Supplement 18Labeling | Approved | None posted |
| Dec 21, 2006 | Supplement 8Labeling | Approved | None posted |
| Dec 15, 2006 | Supplement 7Labeling | Approved | None posted |
| Dec 13, 2006 | Supplement 6Manufacturing | Approved | None posted |
| Mar 22, 2005 | Supplement 5Labeling | Approved | None posted |
| Jul 13, 2004 | Supplement 3 | Approved | |
| Jun 5, 2002 | Original application | 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
