SYNTHROID — FDA application NDA021402
Listed sponsor: ABBVIE · ABBV company profile · exact_unique
Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.
FDA application facts
| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
|---|---|---|---|---|---|---|---|---|
| 001 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET | ORAL | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Prescription | AB1,AB2 | Yes |
| 002 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET | ORAL | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Prescription | AB1,AB2 | Yes |
| 003 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET | ORAL | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Prescription | AB1,AB2 | Yes |
| 004 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET | ORAL | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Prescription | AB1,AB2 | Yes |
| 005 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET | ORAL | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Prescription | AB1,AB2 | Yes |
| 006 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET | ORAL | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Prescription | AB1,AB2 | Yes |
| 007 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET | ORAL | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Prescription | AB1,AB2 | Yes |
| 008 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET | ORAL | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Prescription | AB1,AB2 | Yes |
| 009 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET | ORAL | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Prescription | AB1,AB2 | Yes |
| 010 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET | ORAL | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Prescription | AB1,AB2 | Yes |
| 011 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET | ORAL | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Prescription | AB1,AB2 | Yes |
| 012 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET | ORAL | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Prescription | AB1,AB2 | Yes |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
No Orange Book patent or exclusivity listings joined to this application.
Compound cross-links
- LEVOTHYROXINE SODIUM · UNII 9J765S329G · no lmmol compound match
Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.
Related pages
Sponsor company · FDA-approved application index
Peer clusters: Large-cap biopharma
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.