Application 076752
- Type
- ANDA
- Sponsor
- MERCK KGAA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.025MG | No | No |
| 002 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.05MG | No | No |
| 003 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.075MG | No | No |
| 004 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.088MG | No | No |
| 005 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.1MG | No | No |
| 006 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.112MG | No | No |
| 007 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.125MG | No | No |
| 008 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.15MG | No | No |
| 009 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.175MG | No | No |
| 010 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.2MG | No | No |
| 011 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.3MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076752-001 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.025MG | TABLET / ORAL | 2005-06-16 | ||
| A076752-002 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.05MG | TABLET / ORAL | 2005-06-16 | ||
| A076752-003 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.075MG | TABLET / ORAL | 2005-06-16 | ||
| A076752-004 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.088MG | TABLET / ORAL | 2005-06-16 | ||
| A076752-005 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.1MG | TABLET / ORAL | 2005-06-16 | ||
| A076752-006 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.112MG | TABLET / ORAL | 2005-06-16 | ||
| A076752-007 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.125MG | TABLET / ORAL | 2005-06-16 | ||
| A076752-008 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.15MG | TABLET / ORAL | 2005-06-16 | ||
| A076752-009 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.175MG | TABLET / ORAL | 2005-06-16 | ||
| A076752-010 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.2MG | TABLET / ORAL | 2005-06-16 | ||
| A076752-011 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.3MG | TABLET / ORAL | 2005-06-16 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A076752-001 | LEVOTHYROXINE SODIUM | 0.025MG | TABLET / ORAL | 2005-06-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076752-002 | LEVOTHYROXINE SODIUM | 0.05MG | TABLET / ORAL | 2005-06-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076752-003 | LEVOTHYROXINE SODIUM | 0.075MG | TABLET / ORAL | 2005-06-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076752-004 | LEVOTHYROXINE SODIUM | 0.088MG | TABLET / ORAL | 2005-06-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076752-005 | LEVOTHYROXINE SODIUM | 0.1MG | TABLET / ORAL | 2005-06-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076752-006 | LEVOTHYROXINE SODIUM | 0.112MG | TABLET / ORAL | 2005-06-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076752-007 | LEVOTHYROXINE SODIUM | 0.125MG | TABLET / ORAL | 2005-06-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076752-008 | LEVOTHYROXINE SODIUM | 0.15MG | TABLET / ORAL | 2005-06-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076752-009 | LEVOTHYROXINE SODIUM | 0.175MG | TABLET / ORAL | 2005-06-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076752-010 | LEVOTHYROXINE SODIUM | 0.2MG | TABLET / ORAL | 2005-06-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076752-011 | LEVOTHYROXINE SODIUM | 0.3MG | TABLET / ORAL | 2005-06-16 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076752-001 | LEVOTHYROXINE SODIUM | 0.025MG | TABLET / ORAL | 2005-06-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076752-002 | LEVOTHYROXINE SODIUM | 0.05MG | TABLET / ORAL | 2005-06-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076752-003 | LEVOTHYROXINE SODIUM | 0.075MG | TABLET / ORAL | 2005-06-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076752-004 | LEVOTHYROXINE SODIUM | 0.088MG | TABLET / ORAL | 2005-06-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076752-005 | LEVOTHYROXINE SODIUM | 0.1MG | TABLET / ORAL | 2005-06-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076752-006 | LEVOTHYROXINE SODIUM | 0.112MG | TABLET / ORAL | 2005-06-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076752-007 | LEVOTHYROXINE SODIUM | 0.125MG | TABLET / ORAL | 2005-06-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076752-008 | LEVOTHYROXINE SODIUM | 0.15MG | TABLET / ORAL | 2005-06-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076752-009 | LEVOTHYROXINE SODIUM | 0.175MG | TABLET / ORAL | 2005-06-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076752-010 | LEVOTHYROXINE SODIUM | 0.2MG | TABLET / ORAL | 2005-06-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076752-011 | LEVOTHYROXINE SODIUM | 0.3MG | TABLET / ORAL | 2005-06-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076752-001 | LEVOTHYROXINE SODIUM | 0.025MG | TABLET / ORAL | 2005-06-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076752-002 | LEVOTHYROXINE SODIUM | 0.05MG | TABLET / ORAL | 2005-06-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076752-003 | LEVOTHYROXINE SODIUM | 0.075MG | TABLET / ORAL | 2005-06-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076752-004 | LEVOTHYROXINE SODIUM | 0.088MG | TABLET / ORAL | 2005-06-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076752-005 | LEVOTHYROXINE SODIUM | 0.1MG | TABLET / ORAL | 2005-06-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076752-006 | LEVOTHYROXINE SODIUM | 0.112MG | TABLET / ORAL | 2005-06-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076752-007 | LEVOTHYROXINE SODIUM | 0.125MG | TABLET / ORAL | 2005-06-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076752-008 | LEVOTHYROXINE SODIUM | 0.15MG | TABLET / ORAL | 2005-06-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076752-009 | LEVOTHYROXINE SODIUM | 0.175MG | TABLET / ORAL | 2005-06-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076752-010 | LEVOTHYROXINE SODIUM | 0.2MG | TABLET / ORAL | 2005-06-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076752-011 | LEVOTHYROXINE SODIUM | 0.3MG | TABLET / ORAL | 2005-06-16 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076752-001 | LEVOTHYROXINE SODIUM | 0.025MG | TABLET / ORAL | 2005-06-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076752-002 | LEVOTHYROXINE SODIUM | 0.05MG | TABLET / ORAL | 2005-06-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076752-003 | LEVOTHYROXINE SODIUM | 0.075MG | TABLET / ORAL | 2005-06-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076752-004 | LEVOTHYROXINE SODIUM | 0.088MG | TABLET / ORAL | 2005-06-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076752-005 | LEVOTHYROXINE SODIUM | 0.1MG | TABLET / ORAL | 2005-06-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076752-006 | LEVOTHYROXINE SODIUM | 0.112MG | TABLET / ORAL | 2005-06-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076752-007 | LEVOTHYROXINE SODIUM | 0.125MG | TABLET / ORAL | 2005-06-16 | 6a471c1ec25d… |
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 ANHYDROUS | ONESOURCE SPECIALTY PHARMA LIMITED | ae9954a5-e196-449c-abea-ebe4afbee517 | 2026-08-12 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Alvogen, Inc. | 4ddcaec1-a58f-340b-9bc1-bbe048b8c885 | 2026-08-03 | Boxed warning, Warnings, Adverse reactions | levothyroxine sodium 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 |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | c8ae9dc4-836f-4912-80d7-684fd374f40a | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Coupler LLC | 52cce695-4363-8a2c-e063-6294a90a1bbf | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Coupler LLC | 52cd19e4-a4b3-ecee-e063-6394a90ac33b | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | db5cba81-9ad5-42ad-ac9e-a967337630f2 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | d9ccea69-109d-44cf-927b-4ff67652b6a0 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals Inc. | 4f40db1e-3dd9-4c7b-93e6-64f0fd10d551 | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 50978a14-fd72-4c76-927f-667a1f097b87 | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |