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 | 87333260-fe57-4d99-886c-7c66cb063898 | 2026-03-19 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 52a07ade-4098-477d-874e-dd692667041e | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 67f46137-afc4-471b-a6c7-9c2aef92da5d | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | PD-Rx Pharmaceuticals, Inc. | 70a9bb5c-2259-405e-8d89-cc1db8c70743 | 2026-02-25 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | PD-Rx Pharmaceuticals, Inc. | 6f4998ac-0714-4f5d-8944-9e6902b9f0a6 | 2026-02-25 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 853d9e86-2b5b-4967-8c22-70ad34f03418 | 2026-02-20 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | A-S Medication Solutions | b42fe9dd-8383-4839-9eab-393de388da71 | 2026-02-20 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | fa7dd488-de7e-4f9e-87db-18391b723aad | 2026-02-19 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 394b1006-c160-4668-8684-82d1c4481202 | 2026-02-12 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 8e11401b-f5c2-42ac-ba63-2e71b5626b7e | 2026-02-12 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 4520fae0-acce-47a0-af9e-f4f16ea6b268 | 2026-02-12 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 2ce47caf-6ece-429c-b5d7-c47ba6952800 | 2026-02-12 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 99df68ea-4de7-4825-a6d7-894c70d01c28 | 2026-02-10 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 4f26f9dc-cf49-4b55-a6f7-f2f579893ee4 | 2026-02-10 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 2b737395-0238-400b-95ff-890b95c98425 | 2026-02-06 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | ASCLEMED USA INC. | 42a26f8a-dc67-42e4-abb0-d2602afb1b7d | 2026-02-06 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 1ac29774-2b53-4a3f-97fa-16c2880a0868 | 2026-02-06 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | b717aff6-f754-458d-be87-d12d87c5da00 | 2026-02-02 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 62de26a8-d6fc-463f-abe6-4656228c3142 | 2026-02-02 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| EUTHYROX | LEVOTHYROXINE SODIUM | Provell Pharmaceuticals, LLC | bc3c6830-ba68-4ba3-9896-a12d0ad0b275 | 2026-01-27 | Boxed warning, Warnings, Adverse reactions | 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 |