Application 213256
- 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 | 0.088MG | No | No |
| 002 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.1MG | No | No |
| 003 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.125MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213256-001 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.088MG | CAPSULE / ORAL | 2021-01-06 | ||
| A213256-002 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.1MG | CAPSULE / ORAL | 2021-01-06 | ||
| A213256-003 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.125MG | CAPSULE / ORAL | 2021-01-06 |
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 | A213256-001 | LEVOTHYROXINE SODIUM | 0.088MG | CAPSULE / ORAL | 2021-01-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A213256-002 | LEVOTHYROXINE SODIUM | 0.1MG | CAPSULE / ORAL | 2021-01-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A213256-003 | LEVOTHYROXINE SODIUM | 0.125MG | CAPSULE / ORAL | 2021-01-06 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213256-001 | LEVOTHYROXINE SODIUM | 0.088MG | CAPSULE / ORAL | 2021-01-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213256-002 | LEVOTHYROXINE SODIUM | 0.1MG | CAPSULE / ORAL | 2021-01-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213256-003 | LEVOTHYROXINE SODIUM | 0.125MG | CAPSULE / ORAL | 2021-01-06 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213256-001 | LEVOTHYROXINE SODIUM | 0.088MG | CAPSULE / ORAL | 2021-01-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213256-002 | LEVOTHYROXINE SODIUM | 0.1MG | CAPSULE / ORAL | 2021-01-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213256-003 | LEVOTHYROXINE SODIUM | 0.125MG | CAPSULE / ORAL | 2021-01-06 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213256-001 | LEVOTHYROXINE SODIUM | 0.088MG | CAPSULE / ORAL | 2021-01-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213256-002 | LEVOTHYROXINE SODIUM | 0.1MG | CAPSULE / ORAL | 2021-01-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213256-003 | LEVOTHYROXINE SODIUM | 0.125MG | CAPSULE / ORAL | 2021-01-06 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213256-001 | LEVOTHYROXINE SODIUM | 0.088MG | CAPSULE / ORAL | 2021-01-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213256-002 | LEVOTHYROXINE SODIUM | 0.1MG | CAPSULE / ORAL | 2021-01-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213256-003 | LEVOTHYROXINE SODIUM | 0.125MG | CAPSULE / ORAL | 2021-01-06 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213256-001 | LEVOTHYROXINE SODIUM | 0.088MG | CAPSULE / ORAL | 2021-01-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213256-002 | LEVOTHYROXINE SODIUM | 0.1MG | CAPSULE / ORAL | 2021-01-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213256-003 | LEVOTHYROXINE SODIUM | 0.125MG | CAPSULE / ORAL | 2021-01-06 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213256-001 | LEVOTHYROXINE SODIUM | 0.088MG | CAPSULE / ORAL | 2021-01-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213256-002 | LEVOTHYROXINE SODIUM | 0.1MG | CAPSULE / ORAL | 2021-01-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213256-003 | LEVOTHYROXINE SODIUM | 0.125MG | CAPSULE / ORAL | 2021-01-06 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213256-001 | LEVOTHYROXINE SODIUM | 0.088MG | CAPSULE / ORAL | 2021-01-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213256-002 | LEVOTHYROXINE SODIUM | 0.1MG | CAPSULE / ORAL | 2021-01-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213256-003 | LEVOTHYROXINE SODIUM | 0.125MG | CAPSULE / ORAL | 2021-01-06 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213256-001 | LEVOTHYROXINE SODIUM | 0.088MG | CAPSULE / ORAL | 2021-01-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213256-002 | LEVOTHYROXINE SODIUM | 0.1MG | CAPSULE / ORAL | 2021-01-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213256-003 | LEVOTHYROXINE SODIUM | 0.125MG | CAPSULE / ORAL | 2021-01-06 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213256-001 | LEVOTHYROXINE SODIUM | 0.088MG | CAPSULE / ORAL | 2021-01-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213256-002 | LEVOTHYROXINE SODIUM | 0.1MG | CAPSULE / ORAL | 2021-01-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213256-003 | LEVOTHYROXINE SODIUM | 0.125MG | CAPSULE / ORAL | 2021-01-06 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213256-001 | LEVOTHYROXINE SODIUM | 0.088MG | CAPSULE / ORAL | 2021-01-06 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213256-002 | LEVOTHYROXINE SODIUM | 0.1MG | CAPSULE / ORAL | 2021-01-06 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213256-003 | LEVOTHYROXINE SODIUM | 0.125MG | CAPSULE / ORAL | 2021-01-06 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213256-001 | LEVOTHYROXINE SODIUM | 0.088MG | CAPSULE / ORAL | 2021-01-06 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213256-002 | LEVOTHYROXINE SODIUM | 0.1MG | CAPSULE / ORAL | 2021-01-06 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213256-003 | LEVOTHYROXINE SODIUM | 0.125MG | CAPSULE / ORAL | 2021-01-06 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213256-001 | LEVOTHYROXINE SODIUM | 0.088MG | CAPSULE / ORAL | 2021-01-06 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213256-002 | LEVOTHYROXINE SODIUM | 0.1MG | CAPSULE / ORAL | 2021-01-06 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213256-003 | LEVOTHYROXINE SODIUM | 0.125MG | CAPSULE / ORAL | 2021-01-06 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213256-001 | LEVOTHYROXINE SODIUM | 0.088MG | CAPSULE / ORAL | 2021-01-06 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213256-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213256-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213256-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A213256-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A213256-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A213256-003 | AB | 1 | 5aa47cf7b7d7… |
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 | Northwind Health Company, LLC | ffc34bc6-5de5-addb-e053-6294a90a25be | 2026-01-26 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | NuCare Pharmaceuticals, Inc. | 49136b34-1bc1-ec4e-e063-6394a90ac9dd | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | f2bed4e7-86e9-430e-80d9-7bd7cfcf9bf5 | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | levothyroxine sodium LEVOTHYROXINE SODIUM |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 8f7dc71e-4a48-4ba5-945b-f340ff51636e | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 36af0286-e447-4098-b3f2-772debd58667 | 2026-01-20 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | e8142948-2bde-4f4b-931e-da43e91f2d59 | 2026-01-20 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | d29bc0fd-5587-4a70-a505-f5aee1f115a6 | 2026-01-20 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | d5b11dac-1acd-4aa2-b837-e3b90d4f6922 | 2026-01-20 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Northwind Health Company, LLC | f6c92836-95e1-1402-e053-6394a90a2f5e | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | e2291336-1188-48f4-af52-d12ac892f80f | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 98d7ce2b-a248-4ed0-a2ec-d28ba623531e | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals, Inc. | 59a99739-2da5-46a7-8811-1169123bed9b | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | levothyroxine sodium LEVOTHYROXINE SODIUM |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals, Inc. | 579b1935-77f5-4381-9cb0-e0130e4834e8 | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | levothyroxine sodium LEVOTHYROXINE SODIUM |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals, Inc. | 4e6dce46-cbf5-4353-9d0c-36b6f857197a | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Lannett Company, Inc | a8db0f7d-8863-9309-e053-2995a90a284a | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | NuCare Pharmaceuticals, Inc. | 3d737f79-7fc9-4221-e063-6394a90ac9aa | 2026-01-07 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Northwind Health Company, LLC | c968836a-f94c-4d13-e053-2995a90a8df5 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Northwind Health Company, LLC | db10e666-6204-56cc-e053-2995a90a9e08 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Northwind Health Company, LLC | db5dd9d2-4f96-25d0-e053-2995a90af9dc | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | levothyroxine sodium LEVOTHYROXINE SODIUM |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Northwind Health Company, LLC | c9f4923e-5625-1d4f-e053-2a95a90aabc9 | 2026-01-01 | 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 |
|---|---|---|
| 66063 | ORIG | 2021-02-02 |