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 |
|---|---|---|---|---|---|---|---|---|---|
| 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… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211369-005 | LEVOTHYROXINE SODIUM | 0.137MG | CAPSULE / ORAL | 2023-05-02 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211369-006 | LEVOTHYROXINE SODIUM | 0.175MG | CAPSULE / ORAL | 2023-05-02 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211369-001 | LEVOTHYROXINE SODIUM | 0.075MG | CAPSULE / ORAL | 2020-10-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211369-002 | LEVOTHYROXINE SODIUM | 0.15MG | CAPSULE / ORAL | 2020-10-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211369-003 | LEVOTHYROXINE SODIUM | 0.112MG | CAPSULE / ORAL | 2021-04-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211369-004 | LEVOTHYROXINE SODIUM | 0.2MG | CAPSULE / ORAL | 2022-11-09 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211369-005 | LEVOTHYROXINE SODIUM | 0.137MG | CAPSULE / ORAL | 2023-05-02 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211369-006 | LEVOTHYROXINE SODIUM | 0.175MG | CAPSULE / ORAL | 2023-05-02 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211369-001 | LEVOTHYROXINE SODIUM | 0.075MG | CAPSULE / ORAL | 2020-10-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211369-002 | LEVOTHYROXINE SODIUM | 0.15MG | CAPSULE / ORAL | 2020-10-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211369-003 | LEVOTHYROXINE SODIUM | 0.112MG | CAPSULE / ORAL | 2021-04-16 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211369-004 | LEVOTHYROXINE SODIUM | 0.2MG | CAPSULE / ORAL | 2022-11-09 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211369-005 | LEVOTHYROXINE SODIUM | 0.137MG | CAPSULE / ORAL | 2023-05-02 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211369-006 | LEVOTHYROXINE SODIUM | 0.175MG | CAPSULE / ORAL | 2023-05-02 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211369-001 | LEVOTHYROXINE SODIUM | 0.075MG | CAPSULE / ORAL | 2020-10-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211369-002 | LEVOTHYROXINE SODIUM | 0.15MG | CAPSULE / ORAL | 2020-10-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211369-003 | LEVOTHYROXINE SODIUM | 0.112MG | CAPSULE / ORAL | 2021-04-16 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211369-004 | LEVOTHYROXINE SODIUM | 0.2MG | CAPSULE / ORAL | 2022-11-09 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211369-005 | LEVOTHYROXINE SODIUM | 0.137MG | CAPSULE / ORAL | 2023-05-02 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211369-006 | LEVOTHYROXINE SODIUM | 0.175MG | CAPSULE / ORAL | 2023-05-02 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211369-001 | LEVOTHYROXINE SODIUM | 0.075MG | CAPSULE / ORAL | 2020-10-28 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211369-002 | LEVOTHYROXINE SODIUM | 0.15MG | CAPSULE / ORAL | 2020-10-28 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211369-003 | LEVOTHYROXINE SODIUM | 0.112MG | CAPSULE / ORAL | 2021-04-16 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211369-004 | LEVOTHYROXINE SODIUM | 0.2MG | CAPSULE / ORAL | 2022-11-09 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211369-005 | LEVOTHYROXINE SODIUM | 0.137MG | CAPSULE / ORAL | 2023-05-02 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211369-006 | LEVOTHYROXINE SODIUM | 0.175MG | CAPSULE / ORAL | 2023-05-02 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211369-001 | LEVOTHYROXINE SODIUM | 0.075MG | CAPSULE / ORAL | 2020-10-28 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211369-002 | LEVOTHYROXINE SODIUM | 0.15MG | CAPSULE / ORAL | 2020-10-28 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211369-003 | LEVOTHYROXINE SODIUM | 0.112MG | CAPSULE / ORAL | 2021-04-16 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211369-004 | LEVOTHYROXINE SODIUM | 0.2MG | CAPSULE / ORAL | 2022-11-09 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211369-005 | LEVOTHYROXINE SODIUM | 0.137MG | CAPSULE / ORAL | 2023-05-02 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211369-006 | LEVOTHYROXINE SODIUM | 0.175MG | CAPSULE / ORAL | 2023-05-02 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211369-001 | LEVOTHYROXINE SODIUM | 0.075MG | CAPSULE / ORAL | 2020-10-28 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211369-002 | LEVOTHYROXINE SODIUM | 0.15MG | CAPSULE / ORAL | 2020-10-28 | 79d66fd596c7… |
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 | REMEDYREPACK INC. | bc9385d0-5c67-4bde-94da-e621347e2cba | 2026-09-10 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | REMEDYREPACK INC. | 4c903249-69e9-4168-a9d1-22e6c2c1eb22 | 2026-09-10 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | REMEDYREPACK INC. | 6f25cbb3-0358-4778-b8f0-f76479a2dcc5 | 2026-09-10 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | REMEDYREPACK INC. | 7fd988be-ab3d-406d-a55d-1e5a8a2101cc | 2026-09-10 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | REMEDYREPACK INC. | 6108759a-783e-42ca-b078-6a3cd84ce901 | 2026-09-10 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | REMEDYREPACK INC. | 13e03769-9a4f-497f-9afa-95bf525090b3 | 2026-09-09 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | NorthStar RxLLC | 58f4dc90-3648-49dc-a7e1-baf918a773b5 | 2026-08-20 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | NuCare Pharmaceuticals, Inc. | 597ea445-d926-adc6-e063-6394a90a6446 | 2026-08-20 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | ONESOURCE SPECIALTY PHARMA LIMITED | ae9954a5-e196-449c-abea-ebe4afbee517 | 2026-08-12 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Coupler LLC | 55f4c679-86cb-b97f-e063-6294a90ad5ef | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Coupler LLC | 55f67831-4680-edbf-e063-6294a90a1d36 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 489ffba8-983e-478f-8f62-fe08bf3d0e0b | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Coupler LLC | 544d67eb-8487-cb5d-e063-6394a90a3110 | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 3b282e57-1009-4d2c-8ca2-9cca9f791937 | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Coupler LLC | 53e84179-fe2a-5696-e063-6394a90a8566 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | Coupler LLC | 5383a4d8-319a-5bf6-e063-6294a90a5497 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | NCS HealthCare of KY, LLC dba Vangard Labs | abe173cc-1579-43a5-b12d-a31958d0a539 | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Cardinal Health 107, LLC | 66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Coupler LLC | 53316e75-9897-4935-e063-6294a90a94cf | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 5852d874-1ebc-49ff-b6c2-1dd513fca784 | 2026-05-27 | 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 |