Application 021924
- Type
- NDA
- Sponsor
- INSTITUT BIOCHIMIQUE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.025MG | Yes | No |
| 003 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.05MG | Yes | No |
| 004 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.075MG | Yes | No |
| 005 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.1MG | Yes | No |
| 006 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.125MG | Yes | No |
| 007 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.15MG | Yes | No |
| 008 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.112MG | Yes | No |
| 009 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.137MG | Yes | No |
| 010 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.088MG | Yes | No |
| 011 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.175MG | Yes | No |
| 012 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.200MG | Yes | Yes |
| 013 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.013MG | Yes | No |
| 014 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.0375MG | Yes | No |
| 015 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.044MG | Yes | No |
| 016 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.0625MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021924-002 | TIROSINT | LEVOTHYROXINE SODIUM | 0.025MG | CAPSULE / ORAL | RLD | 2006-10-13 | |
| N021924-003 | TIROSINT | LEVOTHYROXINE SODIUM | 0.05MG | CAPSULE / ORAL | RLD | 2006-10-13 | |
| N021924-004 | TIROSINT | LEVOTHYROXINE SODIUM | 0.075MG | CAPSULE / ORAL | RLD | 2006-10-13 | |
| N021924-005 | TIROSINT | LEVOTHYROXINE SODIUM | 0.1MG | CAPSULE / ORAL | RLD | 2006-10-13 | |
| N021924-006 | TIROSINT | LEVOTHYROXINE SODIUM | 0.125MG | CAPSULE / ORAL | RLD | 2006-10-13 | |
| N021924-007 | TIROSINT | LEVOTHYROXINE SODIUM | 0.15MG | CAPSULE / ORAL | RLD | 2006-10-13 | |
| N021924-008 | TIROSINT | LEVOTHYROXINE SODIUM | 0.112MG | CAPSULE / ORAL | RLD | 2009-10-02 | |
| N021924-009 | TIROSINT | LEVOTHYROXINE SODIUM | 0.137MG | CAPSULE / ORAL | RLD | 2009-10-02 | |
| N021924-010 | TIROSINT | LEVOTHYROXINE SODIUM | 0.088MG | CAPSULE / ORAL | RLD | 2009-10-02 | |
| N021924-011 | TIROSINT | LEVOTHYROXINE SODIUM | 0.175MG | CAPSULE / ORAL | RLD | 2017-04-25 | |
| N021924-012 | TIROSINT | LEVOTHYROXINE SODIUM | 0.2MG | CAPSULE / ORAL | RLD, RS | 2017-04-25 | |
| N021924-013 | TIROSINT | LEVOTHYROXINE SODIUM | 0.013MG | CAPSULE / ORAL | RLD | 2007-08-01 | |
| N021924-014 | TIROSINT | LEVOTHYROXINE SODIUM | 0.0375MG | CAPSULE / ORAL | RLD | 2022-06-22 | |
| N021924-015 | TIROSINT | LEVOTHYROXINE SODIUM | 0.044MG | CAPSULE / ORAL | RLD | 2022-06-22 | |
| N021924-016 | TIROSINT | LEVOTHYROXINE SODIUM | 0.0625MG | CAPSULE / ORAL | RLD | 2022-06-22 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N021924-002 | 12564565 | 2044-09-26 | Drug product | 2026-03-20 | |
| N021924-003 | 12564565 | 2044-09-26 | Drug product | 2026-03-20 | |
| N021924-004 | 12564565 | 2044-09-26 | Drug product | 2026-03-20 | |
| N021924-005 | 12564565 | 2044-09-26 | Drug product | 2026-03-20 | |
| N021924-006 | 12564565 | 2044-09-26 | Drug product | 2026-03-20 | |
| N021924-007 | 12564565 | 2044-09-26 | Drug product | 2026-03-20 | |
| N021924-008 | 12564565 | 2044-09-26 | Drug product | 2026-03-20 | |
| N021924-009 | 12564565 | 2044-09-26 | Drug product | 2026-03-20 | |
| N021924-010 | 12564565 | 2044-09-26 | Drug product | 2026-03-20 | |
| N021924-011 | 12564565 | 2044-09-26 | Drug product | 2026-03-20 | |
| N021924-012 | 12564565 | 2044-09-26 | Drug product | 2026-03-20 | |
| N021924-013 | 12564565 | 2044-09-26 | Drug product | 2026-03-20 | |
| N021924-014 | 12564565 | 2044-09-26 | Drug product | 2026-03-20 | |
| N021924-015 | 12564565 | 2044-09-26 | Drug product | 2026-03-20 | |
| N021924-016 | 12564565 | 2044-09-26 | Drug product | 2026-03-20 |
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 | N021924-002 | TIROSINT | 0.025MG | CAPSULE / ORAL | RLD | 2006-10-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021924-003 | TIROSINT | 0.05MG | CAPSULE / ORAL | RLD | 2006-10-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021924-004 | TIROSINT | 0.075MG | CAPSULE / ORAL | RLD | 2006-10-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021924-005 | TIROSINT | 0.1MG | CAPSULE / ORAL | RLD | 2006-10-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021924-006 | TIROSINT | 0.125MG | CAPSULE / ORAL | RLD | 2006-10-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021924-007 | TIROSINT | 0.15MG | CAPSULE / ORAL | RLD | 2006-10-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021924-008 | TIROSINT | 0.112MG | CAPSULE / ORAL | RLD | 2009-10-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021924-009 | TIROSINT | 0.137MG | CAPSULE / ORAL | RLD | 2009-10-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021924-010 | TIROSINT | 0.088MG | CAPSULE / ORAL | RLD | 2009-10-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021924-011 | TIROSINT | 0.175MG | CAPSULE / ORAL | RLD | 2017-04-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021924-012 | TIROSINT | 0.2MG | CAPSULE / ORAL | RLD, RS | 2017-04-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021924-013 | TIROSINT | 0.013MG | CAPSULE / ORAL | RLD | 2007-08-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021924-014 | TIROSINT | 0.0375MG | CAPSULE / ORAL | RLD | 2022-06-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021924-015 | TIROSINT | 0.044MG | CAPSULE / ORAL | RLD | 2022-06-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021924-016 | TIROSINT | 0.0625MG | CAPSULE / ORAL | RLD | 2022-06-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021924-002 | TIROSINT | 0.025MG | CAPSULE / ORAL | RLD | 2006-10-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021924-003 | TIROSINT | 0.05MG | CAPSULE / ORAL | RLD | 2006-10-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021924-004 | TIROSINT | 0.075MG | CAPSULE / ORAL | RLD | 2006-10-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021924-005 | TIROSINT | 0.1MG | CAPSULE / ORAL | RLD | 2006-10-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021924-006 | TIROSINT | 0.125MG | CAPSULE / ORAL | RLD | 2006-10-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021924-007 | TIROSINT | 0.15MG | CAPSULE / ORAL | RLD | 2006-10-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021924-008 | TIROSINT | 0.112MG | CAPSULE / ORAL | RLD | 2009-10-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021924-009 | TIROSINT | 0.137MG | CAPSULE / ORAL | RLD | 2009-10-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021924-010 | TIROSINT | 0.088MG | CAPSULE / ORAL | RLD | 2009-10-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021924-011 | TIROSINT | 0.175MG | CAPSULE / ORAL | RLD | 2017-04-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021924-012 | TIROSINT | 0.2MG | CAPSULE / ORAL | RLD, RS | 2017-04-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021924-013 | TIROSINT | 0.013MG | CAPSULE / ORAL | RLD | 2007-08-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021924-014 | TIROSINT | 0.0375MG | CAPSULE / ORAL | RLD | 2022-06-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021924-015 | TIROSINT | 0.044MG | CAPSULE / ORAL | RLD | 2022-06-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021924-016 | TIROSINT | 0.0625MG | CAPSULE / ORAL | RLD | 2022-06-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021924-002 | TIROSINT | 0.025MG | CAPSULE / ORAL | RLD | 2006-10-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021924-003 | TIROSINT | 0.05MG | CAPSULE / ORAL | RLD | 2006-10-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021924-004 | TIROSINT | 0.075MG | CAPSULE / ORAL | RLD | 2006-10-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021924-005 | TIROSINT | 0.1MG | CAPSULE / ORAL | RLD | 2006-10-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021924-006 | TIROSINT | 0.125MG | CAPSULE / ORAL | RLD | 2006-10-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021924-007 | TIROSINT | 0.15MG | CAPSULE / ORAL | RLD | 2006-10-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021924-008 | TIROSINT | 0.112MG | CAPSULE / ORAL | RLD | 2009-10-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021924-009 | TIROSINT | 0.137MG | CAPSULE / ORAL | RLD | 2009-10-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021924-010 | TIROSINT | 0.088MG | CAPSULE / ORAL | RLD | 2009-10-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021924-011 | TIROSINT | 0.175MG | CAPSULE / ORAL | RLD | 2017-04-25 | 6a471c1ec25d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2021-12-28 21:50 UTC | 2021-12 | N021924-008 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021924-004 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021924-005 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021924-006 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021924-007 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021924-010 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021924-004 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021924-005 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021924-006 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021924-007 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021924-010 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021924-004 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021924-007 | AB | 1 | 8869cabd3fbd… |
| 2023-05-13 08:27 UTC | 2023-05 | N021924-012 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N021924-012 | AB | 1 | 3bdfa0b2c4d7… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021924-002 | 7691411 | 2024-03-14 | Drug product | 2016-09-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021924-002 | 7723390 | 2024-03-14 | Drug product | 2010-05-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021924-003 | 7691411 | 2024-03-14 | Drug product | 2016-09-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021924-003 | 7723390 | 2024-03-14 | Drug product | 2010-05-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021924-004 | 7691411 | 2024-03-14 | Drug product | 2016-09-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021924-004 | 7723390 | 2024-03-14 | Drug product | 2010-05-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021924-005 | 7691411 | 2024-03-14 | Drug product | 2016-09-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021924-005 | 7723390 | 2024-03-14 | Drug product | 2010-05-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021924-006 | 7691411 | 2024-03-14 | Drug product | 2016-09-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021924-006 | 7723390 | 2024-03-14 | Drug product | 2010-05-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021924-007 | 7691411 | 2024-03-14 | Drug product | 2016-09-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021924-007 | 7723390 | 2024-03-14 | Drug product | 2010-05-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021924-008 | 7691411 | 2024-03-14 | Drug product | 2016-09-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021924-008 | 7723390 | 2024-03-14 | Drug product | 2010-05-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021924-009 | 7691411 | 2024-03-14 | Drug product | 2016-09-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021924-009 | 7723390 | 2024-03-14 | Drug product | 2010-05-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021924-010 | 7691411 | 2024-03-14 | Drug product | 2016-09-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021924-010 | 7723390 | 2024-03-14 | Drug product | 2010-05-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021924-011 | 7691411 | 2024-03-14 | Drug product | 2019-10-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021924-011 | 7723390 | 2024-03-14 | Drug product | 2019-10-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021924-012 | 7691411 | 2024-03-14 | Drug product | 2019-10-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021924-012 | 7723390 | 2024-03-14 | Drug product | 2019-10-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021924-013 | 7691411 | 2024-03-14 | Drug product | 2016-09-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021924-013 | 7723390 | 2024-03-14 | Drug product | 2010-05-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021924-002 | 7691411 | 2024-03-14 | Drug product | 2016-09-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021924-002 | 7723390 | 2024-03-14 | Drug product | 2010-05-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021924-003 | 7691411 | 2024-03-14 | Drug product | 2016-09-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021924-003 | 7723390 | 2024-03-14 | Drug product | 2010-05-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021924-004 | 7691411 | 2024-03-14 | Drug product | 2016-09-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021924-004 | 7723390 | 2024-03-14 | Drug product | 2010-05-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021924-005 | 7691411 | 2024-03-14 | Drug product | 2016-09-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021924-005 | 7723390 | 2024-03-14 | Drug product | 2010-05-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021924-006 | 7691411 | 2024-03-14 | Drug product | 2016-09-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021924-006 | 7723390 | 2024-03-14 | Drug product | 2010-05-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021924-007 | 7691411 | 2024-03-14 | Drug product | 2016-09-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021924-007 | 7723390 | 2024-03-14 | Drug product | 2010-05-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021924-008 | 7691411 | 2024-03-14 | Drug product | 2016-09-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021924-008 | 7723390 | 2024-03-14 | Drug product | 2010-05-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021924-009 | 7691411 | 2024-03-14 | Drug product | 2016-09-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021924-009 | 7723390 | 2024-03-14 | Drug product | 2010-05-27 | 2680178bc6a6… |
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 |
|---|---|---|---|---|---|---|
| Tirosint | LEVOTHYROXINE SODIUM | IBSA Pharma Inc. | 7a7ade79-0165-4e31-b84e-667416c00c7e | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | 021924 NDA021924 71858-0005 71858-0010 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | YARAL Pharma Inc. | d28d7202-1278-0486-e053-2995a90af286 | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | 021924 NDA021924 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0527-4951 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4951 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4951 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4951 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4951 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4952 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4952 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4952 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4952 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4952 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4953 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4953 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4953 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4953 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4953 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4954 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4954 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4954 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4954 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4954 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4955 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4955 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4955 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4955 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4955 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4956 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4956 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4956 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4956 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4956 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4957 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4957 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4957 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4957 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4957 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4958 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4958 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4958 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4958 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4958 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4959 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4959 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4959 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4959 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4959 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4960 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4960 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4960 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4960 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4960 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4961 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4961 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4961 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4961 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4961 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4962 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4962 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4962 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4962 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4962 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 24090-490 | Tirosint | Levothyroxine Sodium | Akrimax Pharmaceuticals, LLC | NDA | Current |
| 24090-491 | Tirosint | Levothyroxine Sodium | Akrimax Pharmaceuticals, LLC | NDA | Current |
| 24090-492 | Tirosint | Levothyroxine Sodium | Akrimax Pharmaceuticals, LLC | NDA | Current |
| 24090-493 | Tirosint | Levothyroxine Sodium | Akrimax Pharmaceuticals, LLC | NDA | Current |
| 24090-494 | Tirosint | Levothyroxine Sodium | Akrimax Pharmaceuticals, LLC | NDA | Current |
| 24090-495 | Tirosint | Levothyroxine Sodium | Akrimax Pharmaceuticals, LLC | NDA | Current |
| 24090-496 | Tirosint | Levothyroxine Sodium | Akrimax Pharmaceuticals, LLC | NDA | Current |
| 24090-497 | Tirosint | Levothyroxine Sodium | Akrimax Pharmaceuticals, LLC | NDA | Current |
| 24090-498 | Tirosint | Levothyroxine Sodium | Akrimax Pharmaceuticals, LLC | NDA | Current |
| 24090-499 | Tirosint | Levothyroxine Sodium | Akrimax Pharmaceuticals, LLC | NDA | Current |
| 71858-0005 | Tirosint | levothyroxine sodium | IBSA Pharma Inc. | NDA | Current |
| 71858-0005 | Tirosint | levothyroxine sodium | IBSA Pharma Inc. | NDA | Current |
| 71858-0005 | Tirosint | levothyroxine sodium | IBSA Pharma Inc. | NDA | Current |
| 71858-0005 | Tirosint | levothyroxine sodium | IBSA Pharma Inc. | NDA | Current |
| 71858-0005 | Tirosint | levothyroxine sodium | IBSA Pharma Inc. | NDA | Current |
| 71858-0005 | Tirosint | levothyroxine sodium | IBSA Pharma Inc. | NDA | Current |
| 71858-0005 | Tirosint | levothyroxine sodium | IBSA Pharma Inc. | NDA | Current |
| 71858-0010 | Tirosint | levothyroxine sodium | IBSA Pharma Inc. | NDA | Current |
| 71858-0010 | Tirosint | levothyroxine sodium | IBSA Pharma Inc. | NDA | Current |
| 71858-0010 | Tirosint | levothyroxine sodium | IBSA Pharma Inc. | NDA | Current |