Application 021342
- Type
- NDA
- Sponsor
- CEDIPROF INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVO-T | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 002 | LEVO-T | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 003 | LEVO-T | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 004 | LEVO-T | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 005 | LEVO-T | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 006 | LEVO-T | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 007 | LEVO-T | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 008 | LEVO-T | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 009 | LEVO-T | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 010 | LEVO-T | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 011 | LEVO-T | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 012 | LEVO-T | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.137MG **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 |
|---|---|---|---|---|---|---|---|
| N021342-001 | LEVO-T | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-002 | LEVO-T | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-003 | LEVO-T | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-004 | LEVO-T | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-005 | LEVO-T | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-006 | LEVO-T | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-007 | LEVO-T | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-008 | LEVO-T | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-009 | LEVO-T | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-010 | LEVO-T | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-011 | LEVO-T | LEVOTHYROXINE SODIUM | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | |
| N021342-012 | LEVO-T | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2003-12-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021342-001 | AB1 |
| N021342-001 | AB2 |
| N021342-001 | AB3 |
| N021342-002 | AB1 |
| N021342-002 | AB2 |
| N021342-002 | AB3 |
| N021342-003 | AB1 |
| N021342-003 | AB2 |
| N021342-003 | AB3 |
| N021342-004 | AB1 |
| N021342-004 | AB2 |
| N021342-004 | AB3 |
| N021342-005 | AB1 |
| N021342-005 | AB2 |
| N021342-005 | AB3 |
| N021342-006 | AB1 |
| N021342-006 | AB2 |
| N021342-006 | AB3 |
| N021342-007 | AB1 |
| N021342-007 | AB2 |
| N021342-007 | AB3 |
| N021342-008 | AB1 |
| N021342-008 | AB2 |
| N021342-008 | AB3 |
| N021342-009 | AB1 |
| N021342-009 | AB2 |
| N021342-009 | AB3 |
| N021342-010 | AB1 |
| N021342-010 | AB2 |
| N021342-010 | AB3 |
| N021342-011 | AB1 |
| N021342-011 | AB2 |
| N021342-011 | AB3 |
| N021342-012 | AB1 |
| N021342-012 | AB2 |
| N021342-012 | AB3 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021342-001 | LEVO-T | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021342-002 | LEVO-T | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021342-003 | LEVO-T | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021342-004 | LEVO-T | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021342-005 | LEVO-T | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021342-006 | LEVO-T | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021342-007 | LEVO-T | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021342-008 | LEVO-T | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021342-009 | LEVO-T | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021342-010 | LEVO-T | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021342-011 | LEVO-T | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021342-012 | LEVO-T | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2003-12-08 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021342-001 | LEVO-T | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021342-002 | LEVO-T | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021342-003 | LEVO-T | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021342-004 | LEVO-T | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021342-005 | LEVO-T | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021342-006 | LEVO-T | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021342-007 | LEVO-T | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021342-008 | LEVO-T | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021342-009 | LEVO-T | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021342-010 | LEVO-T | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021342-011 | LEVO-T | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021342-012 | LEVO-T | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2003-12-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-001 | LEVO-T | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-002 | LEVO-T | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-003 | LEVO-T | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-004 | LEVO-T | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-005 | LEVO-T | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-006 | LEVO-T | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-007 | LEVO-T | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-008 | LEVO-T | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-009 | LEVO-T | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-010 | LEVO-T | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-011 | LEVO-T | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021342-012 | LEVO-T | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2003-12-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021342-001 | LEVO-T | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021342-002 | LEVO-T | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021342-003 | LEVO-T | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021342-004 | LEVO-T | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB1,AB2,AB3 | 2002-03-01 | 31067a03dcf5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021342-001 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-001 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-001 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-002 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-002 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-002 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-003 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-003 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-003 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-004 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-004 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-004 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-005 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-005 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-005 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-006 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-006 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-006 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-007 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-007 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-007 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-008 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-008 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-008 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-009 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-009 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-009 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-010 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-010 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-010 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-011 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-011 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-011 | AB3 | 3 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-012 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-012 | AB2 | 2 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021342-012 | AB3 | 3 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021342-001 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021342-001 | AB2 | 2 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021342-001 | AB3 | 3 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021342-002 | AB1 | 1 | caaa826d4ba7… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021342-001 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-002 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-003 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-004 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-005 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-006 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-007 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-008 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-009 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-010 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N021342-011 | 6399101 | 2020-03-30 | 74a2ff9319b5… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-001 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-002 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-003 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-004 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-005 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-006 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-007 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-008 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-009 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-010 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N021342-011 | 6399101 | 2020-03-30 | 8869cabd3fbd… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-001 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-002 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-003 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-004 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-005 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-006 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-007 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-008 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-009 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-010 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N021342-011 | 6399101 | 2020-03-30 | c0c555d07b60… | |||
| 2019-12-14 00:12 UTC | 2019-12 | N021342-001 | 6399101 | 2020-03-30 | 3f01610625f2… | |||
| 2019-12-14 00:12 UTC | 2019-12 | N021342-002 | 6399101 | 2020-03-30 | 3f01610625f2… | |||
| 2019-12-14 00:12 UTC | 2019-12 | N021342-003 | 6399101 | 2020-03-30 | 3f01610625f2… | |||
| 2019-12-14 00:12 UTC | 2019-12 | N021342-004 | 6399101 | 2020-03-30 | 3f01610625f2… | |||
| 2019-12-14 00:12 UTC | 2019-12 | N021342-005 | 6399101 | 2020-03-30 | 3f01610625f2… | |||
| 2019-12-14 00:12 UTC | 2019-12 | N021342-006 | 6399101 | 2020-03-30 | 3f01610625f2… | |||
| 2019-12-14 00:12 UTC | 2019-12 | N021342-007 | 6399101 | 2020-03-30 | 3f01610625f2… |
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 | Bryant Ranch Prepack | 489ffba8-983e-478f-8f62-fe08bf3d0e0b | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 5852d874-1ebc-49ff-b6c2-1dd513fca784 | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | db5cba81-9ad5-42ad-ac9e-a967337630f2 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | d9ccea69-109d-44cf-927b-4ff67652b6a0 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 50978a14-fd72-4c76-927f-667a1f097b87 | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | e293dd94-b523-47a2-8bed-e6d99945ee59 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 776c8dbc-ca34-40f9-9730-4aa59f644703 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 5c1cf991-6177-499d-a9b8-63e5ca92eb79 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 3142571d-f253-45e7-adc1-6ca80d34cab1 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 513d066a-2fcc-44ad-80e1-23c339a56ac6 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 1aaa327d-bb10-4815-8bd3-d8c9edc6c9db | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 64a663ac-ac02-4325-8f21-ee212e546121 | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 4caf9040-5507-45a4-8f42-231aa925ab8d | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 0210a600-747e-433a-8ba9-11692ecfb54a | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | ef7bc627-d37b-470e-b8f7-3c472c930d05 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | d0beda93-9454-4846-b5c6-2a9113fb1765 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 0b9d21d8-9b49-4fd2-b516-b25bc6a6b671 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | caf7825d-f434-472f-94f3-217a41255562 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 73c3d459-dcbf-4458-8edd-2637275a96a1 | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 63629-2094 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 4461bc9f-35db-4211-82ab-7671cf4dc14b | 2026-03-27 | Boxed warning, Warnings, Adverse reactions | 021342 NDA021342 63629-2092 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 63629-2090 | Levothyroxine Sodium | Levothyroxine Sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-2091 | Levothyroxine Sodium | Levothyroxine Sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-2091 | Levothyroxine Sodium | Levothyroxine Sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-2092 | Levothyroxine Sodium | Levothyroxine Sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-2092 | Levothyroxine Sodium | Levothyroxine Sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-2094 | Levothyroxine Sodium | Levothyroxine Sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-2094 | Levothyroxine Sodium | Levothyroxine Sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-6419 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-6419 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-6448 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA | Current |
| 63629-6448 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA | Current |
| 63629-6448 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-6647 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-6647 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-6647 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-6647 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-6699 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-6699 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-6699 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-6699 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-6700 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-6700 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-6750 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-6750 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-6750 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-6750 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-6796 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-6796 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-6796 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-6837 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-6837 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-6838 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-6838 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-8071 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-8071 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-8071 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-8071 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-8072 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-8072 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-8072 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-8072 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-8073 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-8073 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-8073 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-8073 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-8074 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-8074 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-8075 | Levothyroxine Sodium | Levothyroxine Sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-8075 | Levothyroxine Sodium | Levothyroxine Sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-8076 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-8076 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-8077 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-8077 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-8078 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-8078 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-8078 | Levothyroxine sodium | Levothyroxine sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-9188 | Levothyroxine Sodium | Levothyroxine Sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 64725-5181 | Levothyroxine sodium | Levothyroxine sodium | TYA Pharmaceuticals | NDA | Current |
| 66267-130 | Levothyroxine sodium | Levothyroxine sodium | NuCare Pharmaceuticals,Inc. | NDA AUTHORIZED GENERIC | Current |
| 66267-130 | Levothyroxine sodium | Levothyroxine sodium | NuCare Pharmaceuticals,Inc. | NDA AUTHORIZED GENERIC | Current |
| 66267-131 | Levothyroxine sodium | Levothyroxine sodium | NuCare Pharmaceuticals,Inc. | NDA AUTHORIZED GENERIC | Current |
| 66267-131 | Levothyroxine sodium | Levothyroxine sodium | NuCare Pharmaceuticals,Inc. | NDA AUTHORIZED GENERIC | Current |
| 66336-801 | Levothyroxine sodium | Levothyroxine sodium | Dispensing Solutions, Inc. | NDA | Current |
| 68071-2278 | Levothyroxine Sodium | Levothyroxine Sodium | NuCare Pharmaceuticals,Inc. | NDA AUTHORIZED GENERIC | Current |
| 68071-2278 | Levothyroxine Sodium | Levothyroxine Sodium | NuCare Pharmaceuticals,Inc. | NDA AUTHORIZED GENERIC | Current |
| 68071-2623 | Levothyroxine Sodium | Levothyroxine Sodium | NuCare Pharmaceuticals,Inc. | NDA AUTHORIZED GENERIC | Current |
| 68071-3021 | Levothyroxine sodium | Levothyroxine sodium | NuCare Pharmaceuticals, Inc. | NDA | Current |
| 68071-4194 | Levothyroxine sodium | Levothyroxine sodium | NuCare Pharmaceuticals,Inc. | NDA AUTHORIZED GENERIC | Current |
| 68071-4202 | Levothyroxine sodium | Levothyroxine sodium | NuCare Pharmaceuticals,Inc. | NDA AUTHORIZED GENERIC | Current |
| 68071-4624 | Levothyroxine sodium | Levothyroxine sodium | NuCare Pharmaceuticals,Inc. | NDA AUTHORIZED GENERIC | Current |
| 68071-4624 | Levothyroxine sodium | Levothyroxine sodium | NuCare Pharmaceuticals,Inc. | NDA AUTHORIZED GENERIC | Current |
| 68071-4624 | Levothyroxine sodium | Levothyroxine sodium | NuCare Pharmaceuticals,Inc. | NDA AUTHORIZED GENERIC | Current |
| 68071-4625 | Levothyroxine sodium | Levothyroxine sodium | NuCare Pharmaceuticals,Inc. | NDA AUTHORIZED GENERIC | Current |
| 68071-4625 | Levothyroxine sodium | Levothyroxine sodium | NuCare Pharmaceuticals,Inc. | NDA AUTHORIZED GENERIC | Current |
| 68071-4626 | Levothyroxine Sodium | Levothyroxine Sodium | NuCare Pharmaceuticals,Inc. | NDA AUTHORIZED GENERIC | Current |
| 68071-4719 | Levothyroxine sodium | Levothyroxine sodium | NuCare Pharmaceuticals,Inc. | NDA AUTHORIZED GENERIC | Current |
| 68071-4719 | Levothyroxine sodium | Levothyroxine sodium | NuCare Pharmaceuticals,Inc. | NDA AUTHORIZED GENERIC | Current |
| 68071-4719 | Levothyroxine sodium | Levothyroxine sodium | NuCare Pharmaceuticals,Inc. | NDA AUTHORIZED GENERIC | Current |
| 68071-4719 | Levothyroxine sodium | Levothyroxine sodium | NuCare Pharmaceuticals,Inc. | NDA AUTHORIZED GENERIC | Current |
| 68071-4866 | Levothyroxine sodium | Levothyroxine sodium | NuCare Pharmaceuticals,Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85838 | SUPPL | 2026-05-21 |
| 85864 | SUPPL | 2026-05-11 |
| 50625 | SUPPL | 2017-12-07 |
| 50624 | SUPPL | 2017-12-07 |
| 27524 | SUPPL | 2011-03-11 |
| 15222 | SUPPL | 2009-06-22 |
| 27523 | SUPPL | 2009-06-17 |
| 27522 | SUPPL | 2008-06-13 |
| 27521 | SUPPL | 2008-06-13 |
| 36694 | SUPPL | 2008-06-12 |
| 15221 | SUPPL | 2008-06-12 |
| 42112 | SUPPL | 2005-05-13 |
| 42111 | SUPPL | 2005-05-13 |
| 5088 | SUPPL | 2004-06-24 |
| 5087 | SUPPL | 2004-06-24 |
| 36692 | SUPPL | 2003-12-11 |
| 5085 | SUPPL | 2003-12-11 |
| 36693 | SUPPL | 2003-08-28 |
| 5086 | SUPPL | 2003-08-28 |
| 69369 | ORIG | 2002-06-19 |
| 21609 | ORIG | 2002-06-19 |
| 27520 | ORIG | 2002-03-01 |
| 15220 | ORIG | 2002-03-01 |