Application 215259
- Type
- ANDA
- Sponsor
- ASCENT PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 002 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 003 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 004 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 005 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 006 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 007 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 008 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 009 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 010 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 011 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 012 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A215259-001 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | |
| A215259-002 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | |
| A215259-003 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | |
| A215259-004 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | |
| A215259-005 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | |
| A215259-006 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | |
| A215259-007 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | |
| A215259-008 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | |
| A215259-009 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | |
| A215259-010 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | |
| A215259-011 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | |
| A215259-012 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A215259-001 | AB4 |
| A215259-002 | AB4 |
| A215259-003 | AB4 |
| A215259-004 | AB4 |
| A215259-005 | AB4 |
| A215259-006 | AB4 |
| A215259-007 | AB4 |
| A215259-008 | AB4 |
| A215259-009 | AB4 |
| A215259-010 | AB4 |
| A215259-011 | AB4 |
| A215259-012 | AB4 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A215259-001 | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A215259-002 | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A215259-003 | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A215259-004 | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A215259-005 | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A215259-006 | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A215259-007 | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A215259-008 | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A215259-009 | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A215259-010 | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A215259-011 | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A215259-012 | LEVOTHYROXINE SODIUM | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215259-001 | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215259-002 | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215259-003 | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215259-004 | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215259-005 | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215259-006 | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215259-007 | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215259-008 | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215259-009 | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215259-010 | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215259-011 | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215259-012 | LEVOTHYROXINE SODIUM | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215259-001 | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215259-002 | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215259-003 | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215259-004 | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215259-005 | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215259-006 | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215259-007 | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215259-008 | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215259-009 | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215259-010 | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215259-011 | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215259-012 | LEVOTHYROXINE SODIUM | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215259-001 | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215259-002 | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215259-003 | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215259-004 | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB4 | 2023-01-18 | 6a471c1ec25d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A215259-001 | AB4 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A215259-002 | AB4 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A215259-003 | AB4 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A215259-004 | AB4 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A215259-005 | AB4 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A215259-006 | AB4 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A215259-007 | AB4 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A215259-008 | AB4 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A215259-009 | AB4 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A215259-010 | AB4 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A215259-011 | AB4 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A215259-012 | AB4 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A215259-001 | AB4 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215259-002 | AB4 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215259-003 | AB4 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215259-004 | AB4 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215259-005 | AB4 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215259-006 | AB4 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215259-007 | AB4 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215259-008 | AB4 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215259-009 | AB4 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215259-010 | AB4 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215259-011 | AB4 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215259-012 | AB4 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215259-001 | AB4 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215259-002 | AB4 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215259-003 | AB4 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215259-004 | AB4 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215259-005 | AB4 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215259-006 | AB4 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215259-007 | AB4 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215259-008 | AB4 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215259-009 | AB4 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215259-010 | AB4 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215259-011 | AB4 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215259-012 | AB4 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A215259-001 | AB4 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215259-002 | AB4 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215259-003 | AB4 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215259-004 | AB4 | 1 | 6a471c1ec25d… |
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 |
|---|---|---|---|---|---|---|
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | XLCare Pharmaceuticals, Inc. | 51a27110-e787-409b-98ba-c6471d0ad5cf | 2023-02-06 | Boxed warning, Warnings, Adverse reactions | 215259 ANDA215259 |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | Camber Pharmaceuticals, Inc. | b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e | 2023-01-23 | Boxed warning, Warnings, Adverse reactions | 215259 ANDA215259 |