Application 215809
- Type
- NDA
- Sponsor
- MYLAN PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ERMEZA | LEVOTHYROXINE SODIUM | SOLUTION;ORAL | 150MCG/5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N215809-001 | ERMEZA | LEVOTHYROXINE SODIUM | 150MCG/5ML | SOLUTION / ORAL | RLD | 2022-04-29 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 |
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 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD | 2022-04-29 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | 5c6f7cd8ea54… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N215809-001 | ERMEZA | 150MCG/5ML | SOLUTION / ORAL | RLD, RS | 2022-04-29 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | 5c6f7cd8ea54… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N215809-001 | 9345772 | 2035-02-27 | Drug product | 2022-05-13 | a50c72e98297… |
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 | Proficient Rx LP | e1b322a6-9161-45b9-bf77-3c44502d5efd | 2024-05-01 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Mylan Pharmaceuticals Inc. | e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc | 2024-04-15 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | e486f83b-6cf0-4e7d-99ed-cfd19c4501e1 | 2024-04-09 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | d35b5250-c26d-4d67-8a33-2f993b13e3e9 | 2024-04-08 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | d6ce9798-7204-41df-9aeb-067000cb0895 | 2024-04-05 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | Macleods Pharmaceuticals Limited | b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9 | 2024-03-04 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Synthroid | LEVOTHYROXINE SODIUM | AbbVie Inc. | 1e11ad30-1041-4520-10b0-8f9d30d30fcc | 2024-02-20 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 804d64c9-9804-4d6d-adb2-5036c0be8b5c | 2023-12-12 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 3e77de84-6f59-40ac-a1a4-7bfe30387823 | 2023-12-12 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | 89df6a0f-6602-4c22-a052-b565ea8368a7 | 2023-12-01 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 60a0bc29-4283-4ae9-9173-5caf9266f723 | 2023-11-16 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 970b8456-5b9a-4839-9222-4ec1302266e2 | 2023-11-02 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 59762069-5ea7-43d9-ba5b-8b250767b146 | 2023-09-14 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 8bc641d8-0185-49b2-9c1f-d886bf5ce098 | 2023-08-05 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | XLCare Pharmaceuticals, Inc. | 51a27110-e787-409b-98ba-c6471d0ad5cf | 2023-02-06 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | Camber Pharmaceuticals, Inc. | b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e | 2023-01-23 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | 2f129a3d-f3e6-45b2-9704-3ad171cbd8a5 | 2022-08-01 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | 329b6eb2-4fa3-41f6-a6ff-96d94b7a65bf | 2022-07-01 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | 9d1aaa2d-c8c0-478f-8540-f92f6512cfcb | 2022-05-01 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | ca197216-83f1-470a-9313-d1b923924661 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.