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 | 2aab0208-81ad-4607-8196-b4dc5ad5fdaa | 2025-09-05 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 194bc35b-ac82-4a40-bbd4-68eaff50b380 | 2025-09-05 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 37a55040-a9a2-4ff4-8463-9e1c7823d6ff | 2025-08-21 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 2e242b93-bc4f-405a-a194-1981c721ad94 | 2025-08-21 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals Inc. | 609352a9-740f-4874-997b-60b58d0c2b8a | 2025-08-01 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | 9e588c43-b9b5-478e-99f7-e197add3cd26 | 2025-08-01 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | c1b0fbad-5816-4152-ab59-05079e8c2148 | 2025-07-29 | Boxed warning, Warnings, Adverse reactions | levothyroxine sodium LEVOTHYROXINE SODIUM |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 9e3bffb9-f66e-4c73-befc-e60d769f6610 | 2025-07-29 | Boxed warning, Warnings, Adverse reactions | levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals Inc. | 64aaeba7-1013-44a4-96fc-b876016897b3 | 2025-07-25 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Mylan Institutional Inc. | cd69c192-cd3f-47e6-b0a6-c536ffed5c4b | 2025-07-23 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | A-S Medication Solutions | cfab474d-3272-41fd-a8ec-762dd1a84fa6 | 2025-07-23 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | A-S Medication Solutions | b9a50170-ac0b-483e-9e85-1d03b12e4f7d | 2025-07-23 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | REMEDYREPACK INC. | 0fa2e2f5-401b-45c1-b6a5-d02f6faf509d | 2025-07-22 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Mylan Institutional Inc. | 5723c7a7-2a1d-4ab6-bf39-b2165ae781a6 | 2025-07-22 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals, Inc. | 398a00d0-1247-4f6f-b4c1-dade399cc417 | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 70d84fe0-afc4-4ef2-b4d8-f156abac3d1f | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals Inc. | ff7f5eff-4c90-4aa0-8915-704f92dea8aa | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals Inc. | 412fc3f4-d9e0-49c5-b042-a6010aea7e5e | 2025-07-14 | Boxed warning, Warnings, Adverse reactions | levothyroxine sodium LEVOTHYROXINE SODIUM |
| THYQUIDITY | LEVOTHYROXINE SODIUM | Oliva Therapeutics, LLC | 0c839877-50e4-455f-9b6c-462efb09cb96 | 2025-07-03 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals Inc. | 884f9fa1-58aa-4ff7-934f-106a0470e747 | 2025-07-03 | 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 |