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 | Major Pharmaceuticals | 333642fd-93ae-4dc0-9c83-6d6b163c1c74 | 2025-06-19 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | American Health Packaging | 38af4e36-b26b-485d-a6f3-7fbcf6072a0f | 2025-06-16 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | f0680426-3581-400c-8ab5-5e6f18d0cabc | 2025-06-09 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | b4654497-c986-4792-9b6b-0a791c7c205b | 2025-06-06 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 0e0ad9f1-1f52-48ce-a996-79ebe7ad53cd | 2025-06-06 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 247f4d1d-6e65-4f81-a377-4dd88ae16dbb | 2025-05-30 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 70dddaf0-f495-495f-95de-36e9efa2e373 | 2025-05-30 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 91afb351-f067-49a2-bdf0-336ea209718d | 2025-05-29 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 237cc591-c40b-416f-ac00-96cd61bc59dc | 2025-05-23 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | faaa1123-7515-46c2-abbb-b0615540c8cf | 2025-05-22 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 7f8ec438-8ddf-45d2-be94-ac032e192229 | 2025-05-19 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | Fosun Pharma USA Inc. | 3361138a-6e6f-e8df-e063-6294a90af2de | 2025-05-05 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | ENDO USA, Inc. | 9d815416-11c9-470e-a82f-89b0bf232e12 | 2025-04-28 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | f5fc0f34-744c-4e03-ae9f-e017e4033139 | 2025-04-24 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | Fresenius Kabi USA, LLC | ce990712-49c1-4f66-9ee4-c770e8ec394c | 2025-04-17 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 65b266af-72a5-4409-ab55-bd14341135aa | 2025-04-09 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 9ff5ad8e-f28c-4322-be6e-072487878c12 | 2025-04-08 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | NuCare Pharmaceuticals, Inc. | 30ccec8b-3f95-61c7-e063-6394a90a05a0 | 2025-03-20 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Lupin Pharmaceuticals, Inc. | 18717e58-89fb-4e2f-93b6-d6ac3e988d37 | 2025-03-19 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Fresenius Kabi USA, LLC | 08f4b1f8-6807-47e7-bef8-8d1972aa0557 | 2025-03-17 | 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 |