Application 021402
- Type
- NDA
- Sponsor
- ABBVIE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 002 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 003 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 004 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 005 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 006 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 007 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 008 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 009 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 010 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 011 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | Yes |
| 012 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021402-001 | SYNTHROID | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 |
| N021402-002 | SYNTHROID | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 |
| N021402-003 | SYNTHROID | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 |
| N021402-004 | SYNTHROID | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 |
| N021402-005 | SYNTHROID | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 |
| N021402-006 | SYNTHROID | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 |
| N021402-007 | SYNTHROID | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 |
| N021402-008 | SYNTHROID | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 |
| N021402-009 | SYNTHROID | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 |
| N021402-010 | SYNTHROID | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 |
| N021402-011 | SYNTHROID | LEVOTHYROXINE SODIUM | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD, RS | 2002-07-24 |
| N021402-012 | SYNTHROID | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021402-001 | AB1 |
| N021402-001 | AB2 |
| N021402-002 | AB1 |
| N021402-002 | AB2 |
| N021402-003 | AB1 |
| N021402-003 | AB2 |
| N021402-004 | AB1 |
| N021402-004 | AB2 |
| N021402-005 | AB1 |
| N021402-005 | AB2 |
| N021402-006 | AB1 |
| N021402-006 | AB2 |
| N021402-007 | AB1 |
| N021402-007 | AB2 |
| N021402-008 | AB1 |
| N021402-008 | AB2 |
| N021402-009 | AB1 |
| N021402-009 | AB2 |
| N021402-010 | AB1 |
| N021402-010 | AB2 |
| N021402-011 | AB1 |
| N021402-011 | AB2 |
| N021402-012 | AB1 |
| N021402-012 | AB2 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021402-001 | SYNTHROID | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-002 | SYNTHROID | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-003 | SYNTHROID | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-004 | SYNTHROID | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-005 | SYNTHROID | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-006 | SYNTHROID | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-007 | SYNTHROID | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-008 | SYNTHROID | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-009 | SYNTHROID | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-010 | SYNTHROID | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-011 | SYNTHROID | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD, RS | 2002-07-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-012 | SYNTHROID | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021402-001 | SYNTHROID | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021402-002 | SYNTHROID | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021402-003 | SYNTHROID | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021402-004 | SYNTHROID | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021402-005 | SYNTHROID | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021402-006 | SYNTHROID | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021402-007 | SYNTHROID | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021402-008 | SYNTHROID | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021402-009 | SYNTHROID | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021402-010 | SYNTHROID | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021402-011 | SYNTHROID | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD, RS | 2002-07-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021402-012 | SYNTHROID | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021402-001 | SYNTHROID | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021402-002 | SYNTHROID | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021402-003 | SYNTHROID | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021402-004 | SYNTHROID | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021402-005 | SYNTHROID | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021402-006 | SYNTHROID | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021402-007 | SYNTHROID | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021402-008 | SYNTHROID | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021402-009 | SYNTHROID | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021402-010 | SYNTHROID | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021402-011 | SYNTHROID | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD, RS | 2002-07-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021402-012 | SYNTHROID | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021402-001 | SYNTHROID | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021402-002 | SYNTHROID | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021402-003 | SYNTHROID | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021402-004 | SYNTHROID | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2 | RLD | 2002-07-24 | fd3edfee7708… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021402-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-001 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-002 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-003 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-003 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-004 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-004 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-005 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-005 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-006 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-006 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-007 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-007 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-008 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-008 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-009 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-009 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-010 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-010 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-011 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-011 | AB2 | 2 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-012 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021402-012 | AB2 | 2 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021402-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021402-001 | AB2 | 2 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021402-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021402-002 | AB2 | 2 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021402-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021402-003 | AB2 | 2 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021402-004 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021402-004 | AB2 | 2 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021402-005 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021402-005 | AB2 | 2 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021402-006 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021402-006 | AB2 | 2 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021402-007 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021402-007 | AB2 | 2 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021402-008 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021402-008 | AB2 | 2 | 31067a03dcf5… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Synthroid | LEVOTHYROXINE SODIUM | AbbVie Inc. | 1e11ad30-1041-4520-10b0-8f9d30d30fcc | 2024-02-20 | Boxed warning, Warnings, Adverse reactions | 021402 NDA021402 0074-7070 0074-7149 0074-4341 0074-4552 0074-7148 0074-6594 0074-3727 0074-5182 0074-7068 0074-9296 0074-6624 0074-7069 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0074-3727 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-3727 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-3727 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-3727 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-3727 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-3727 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-3727 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-4341 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-4341 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-4341 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-4341 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-4341 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-4341 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-4341 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-4552 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-4552 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-4552 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-4552 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-4552 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-4552 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-4552 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-5182 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-5182 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-5182 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-5182 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-5182 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-5182 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-5182 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-6594 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-6594 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-6594 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-6594 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-6594 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-6594 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-6594 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-6624 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-6624 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-6624 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-6624 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-6624 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-6624 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-6624 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7068 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7068 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7068 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7068 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7068 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7068 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7068 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7069 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7069 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7069 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7069 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7069 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7069 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7069 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7070 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7070 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7070 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7070 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7070 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7070 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7070 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7148 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7148 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7148 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7148 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7148 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7148 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7148 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7149 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7149 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7149 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7149 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7149 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7149 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7149 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-9296 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-9296 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-9296 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 77586 | SUPPL | 2024-02-21 |
| 77590 | SUPPL | 2024-02-20 |
| 71979 | SUPPL | 2022-08-31 |
| 71974 | SUPPL | 2022-08-31 |
| 63965 | SUPPL | 2020-07-20 |
| 63938 | SUPPL | 2020-07-16 |
| 47414 | SUPPL | 2017-03-02 |
| 47413 | SUPPL | 2017-03-02 |
| 47325 | SUPPL | 2017-02-24 |
| 47324 | SUPPL | 2017-02-24 |
| 15373 | SUPPL | 2014-01-15 |
| 5258 | SUPPL | 2012-10-02 |
| 27675 | SUPPL | 2008-07-15 |
| 15372 | SUPPL | 2008-07-15 |
| 36822 | SUPPL | 2008-06-05 |
| 42138 | ORIG | 2002-11-25 |
| 27674 | ORIG | 2002-07-24 |
| 15371 | ORIG | 2002-07-24 |