Application 211369
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.075MG | No | No |
| 002 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.15MG | No | No |
| 003 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.112MG | No | No |
| 004 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.200MG | No | No |
| 005 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.137MG | No | No |
| 006 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.175MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211369-001 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.075MG | CAPSULE / ORAL | 2020-10-28 | ||
| A211369-002 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.15MG | CAPSULE / ORAL | 2020-10-28 | ||
| A211369-003 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.112MG | CAPSULE / ORAL | 2021-04-16 | ||
| A211369-004 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.2MG | CAPSULE / ORAL | 2022-11-09 | ||
| A211369-005 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.137MG | CAPSULE / ORAL | 2023-05-02 | ||
| A211369-006 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.175MG | CAPSULE / ORAL | 2023-05-02 |
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 | A211369-001 | LEVOTHYROXINE SODIUM | 0.075MG | CAPSULE / ORAL | 2020-10-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A211369-002 | LEVOTHYROXINE SODIUM | 0.15MG | CAPSULE / ORAL | 2020-10-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A211369-003 | LEVOTHYROXINE SODIUM | 0.112MG | CAPSULE / ORAL | 2021-04-16 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A211369-004 | LEVOTHYROXINE SODIUM | 0.2MG | CAPSULE / ORAL | 2022-11-09 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A211369-005 | LEVOTHYROXINE SODIUM | 0.137MG | CAPSULE / ORAL | 2023-05-02 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A211369-006 | LEVOTHYROXINE SODIUM | 0.175MG | CAPSULE / ORAL | 2023-05-02 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A211369-001 | LEVOTHYROXINE SODIUM | 0.075MG | CAPSULE / ORAL | 2020-10-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A211369-002 | LEVOTHYROXINE SODIUM | 0.15MG | CAPSULE / ORAL | 2020-10-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A211369-003 | LEVOTHYROXINE SODIUM | 0.112MG | CAPSULE / ORAL | 2021-04-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A211369-004 | LEVOTHYROXINE SODIUM | 0.2MG | CAPSULE / ORAL | 2022-11-09 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A211369-005 | LEVOTHYROXINE SODIUM | 0.137MG | CAPSULE / ORAL | 2023-05-02 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A211369-006 | LEVOTHYROXINE SODIUM | 0.175MG | CAPSULE / ORAL | 2023-05-02 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A211369-001 | LEVOTHYROXINE SODIUM | 0.075MG | CAPSULE / ORAL | 2020-10-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A211369-002 | LEVOTHYROXINE SODIUM | 0.15MG | CAPSULE / ORAL | 2020-10-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A211369-003 | LEVOTHYROXINE SODIUM | 0.112MG | CAPSULE / ORAL | 2021-04-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A211369-004 | LEVOTHYROXINE SODIUM | 0.2MG | CAPSULE / ORAL | 2022-11-09 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A211369-005 | LEVOTHYROXINE SODIUM | 0.137MG | CAPSULE / ORAL | 2023-05-02 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A211369-006 | LEVOTHYROXINE SODIUM | 0.175MG | CAPSULE / ORAL | 2023-05-02 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211369-001 | LEVOTHYROXINE SODIUM | 0.075MG | CAPSULE / ORAL | 2020-10-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211369-002 | LEVOTHYROXINE SODIUM | 0.15MG | CAPSULE / ORAL | 2020-10-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211369-003 | LEVOTHYROXINE SODIUM | 0.112MG | CAPSULE / ORAL | 2021-04-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211369-004 | LEVOTHYROXINE SODIUM | 0.2MG | CAPSULE / ORAL | 2022-11-09 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211369-005 | LEVOTHYROXINE SODIUM | 0.137MG | CAPSULE / ORAL | 2023-05-02 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211369-006 | LEVOTHYROXINE SODIUM | 0.175MG | CAPSULE / ORAL | 2023-05-02 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211369-001 | LEVOTHYROXINE SODIUM | 0.075MG | CAPSULE / ORAL | 2020-10-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211369-002 | LEVOTHYROXINE SODIUM | 0.15MG | CAPSULE / ORAL | 2020-10-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211369-003 | LEVOTHYROXINE SODIUM | 0.112MG | CAPSULE / ORAL | 2021-04-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211369-004 | LEVOTHYROXINE SODIUM | 0.2MG | CAPSULE / ORAL | 2022-11-09 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211369-005 | LEVOTHYROXINE SODIUM | 0.137MG | CAPSULE / ORAL | 2023-05-02 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211369-006 | LEVOTHYROXINE SODIUM | 0.175MG | CAPSULE / ORAL | 2023-05-02 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211369-001 | LEVOTHYROXINE SODIUM | 0.075MG | CAPSULE / ORAL | 2020-10-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211369-002 | LEVOTHYROXINE SODIUM | 0.15MG | CAPSULE / ORAL | 2020-10-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211369-003 | LEVOTHYROXINE SODIUM | 0.112MG | CAPSULE / ORAL | 2021-04-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211369-004 | LEVOTHYROXINE SODIUM | 0.2MG | CAPSULE / ORAL | 2022-11-09 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211369-005 | LEVOTHYROXINE SODIUM | 0.137MG | CAPSULE / ORAL | 2023-05-02 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211369-006 | LEVOTHYROXINE SODIUM | 0.175MG | CAPSULE / ORAL | 2023-05-02 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211369-001 | LEVOTHYROXINE SODIUM | 0.075MG | CAPSULE / ORAL | 2020-10-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211369-002 | LEVOTHYROXINE SODIUM | 0.15MG | CAPSULE / ORAL | 2020-10-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211369-003 | LEVOTHYROXINE SODIUM | 0.112MG | CAPSULE / ORAL | 2021-04-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211369-004 | LEVOTHYROXINE SODIUM | 0.2MG | CAPSULE / ORAL | 2022-11-09 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2021-12-28 21:50 UTC | 2021-12 | A211369-003 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A211369-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A211369-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A211369-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A211369-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A211369-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A211369-002 | AB | 1 | 8869cabd3fbd… |
| 2023-05-13 08:27 UTC | 2023-05 | A211369-004 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A211369-004 | AB | 1 | 3bdfa0b2c4d7… |
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 | A-S Medication Solutions | 8bc641d8-0185-49b2-9c1f-d886bf5ce098 | 2023-08-05 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | XLCare Pharmaceuticals, Inc. | 51a27110-e787-409b-98ba-c6471d0ad5cf | 2023-02-06 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | Camber Pharmaceuticals, Inc. | b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e | 2023-01-23 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | 2f129a3d-f3e6-45b2-9704-3ad171cbd8a5 | 2022-08-01 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | 329b6eb2-4fa3-41f6-a6ff-96d94b7a65bf | 2022-07-01 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | 9d1aaa2d-c8c0-478f-8540-f92f6512cfcb | 2022-05-01 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | ca197216-83f1-470a-9313-d1b923924661 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | 7ceed5ff-fd41-4ebd-ade7-e31b135231c1 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | 2daab9ce-0570-4fdf-a7bd-01c3178f8cf3 | 2021-03-01 | Boxed warning, Warnings, Adverse reactions | levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | 2f0657d5-3e5c-4249-bfaa-7f5ef1528672 | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| LEVOXYL | LEVOTHYROXINE SODIUM | Pfizer Laboratories Div Pfizer Inc | 758588c3-c63e-491b-0aa2-4f50d80cb174 | 2020-12-15 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Fresenius Kabi USA, LLC | 388a1f15-8c1c-46a5-997f-7f326f696b59 | 2020-12-04 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Fresenius Kabi USA, LLC | 50b1c8a4-75b6-49c8-80fc-3841ee80b183 | 2020-12-04 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | 12ccf2fd-ccf0-4bcf-8eee-e2a16c8b44d6 | 2020-12-01 | Boxed warning, Warnings, Adverse reactions | levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | 97e28b00-9913-463f-9de2-08c828edbe67 | 2020-03-01 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | 05ab038e-45fa-488e-a05e-12a2dd3564c1 | 2020-01-01 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | b81720f9-2836-4c1d-8691-0f6acef13316 | 2020-01-01 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | 3019762c-d480-4530-a3b2-762b523e7961 | 2019-11-01 | Boxed warning, Warnings, Adverse reactions | levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | 434075d5-a82b-4f17-85e6-4c1922663dbc | 2019-10-01 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | 18c7c63a-642e-47fe-a8ee-12aaf652b2aa | 2019-10-01 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 65511 | ORIG | 2020-12-07 |