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 | Bryant Ranch Prepack | 775ef7ba-0b5b-40ba-ac7b-2aef121fe4f4 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 231fcdf8-c642-4074-8be8-53ee9c918f18 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 251e65e0-6925-4984-9df9-d6d7c6d0703c | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 3142571d-f253-45e7-adc1-6ca80d34cab1 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 513d066a-2fcc-44ad-80e1-23c339a56ac6 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 741a8b30-86e1-4f37-917a-73265a82ee07 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 1aaa327d-bb10-4815-8bd3-d8c9edc6c9db | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 64a663ac-ac02-4325-8f21-ee212e546121 | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Coupler LLC | 51b68266-95d2-c166-e063-6294a90a534f | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Coupler LLC | 50fe00b3-6610-1cac-e063-6294a90af8ac | 2026-05-04 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Coupler LLC | 5100c561-0028-a3c0-e063-6394a90addeb | 2026-05-04 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | NuCare Pharmaceuticals,Inc. | 510349d0-6397-7e2b-e063-6394a90a8a68 | 2026-05-04 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | f94a81e2-49cd-430a-acda-1a47d5c5b59b | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals Inc. | 4a2c8e57-d52d-409f-83d8-731b721bf613 | 2026-04-20 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 4caf9040-5507-45a4-8f42-231aa925ab8d | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | f347d92a-7726-4165-bc3c-f5b37ec86f9f | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | REMEDYREPACK INC. | f8c14539-8ed1-406a-9b58-8ba3a7ce7ee3 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | Levothyroxine sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 0210a600-747e-433a-8ba9-11692ecfb54a | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | ef7bc627-d37b-470e-b8f7-3c472c930d05 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | Levothyroxine Sodium LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | d0beda93-9454-4846-b5c6-2a9113fb1765 | 2026-04-07 | 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 |