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 | A-S Medication Solutions | 52a07ade-4098-477d-874e-dd692667041e | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 67f46137-afc4-471b-a6c7-9c2aef92da5d | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | PD-Rx Pharmaceuticals, Inc. | 70a9bb5c-2259-405e-8d89-cc1db8c70743 | 2026-02-25 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | PD-Rx Pharmaceuticals, Inc. | 6f4998ac-0714-4f5d-8944-9e6902b9f0a6 | 2026-02-25 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 853d9e86-2b5b-4967-8c22-70ad34f03418 | 2026-02-20 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | A-S Medication Solutions | b42fe9dd-8383-4839-9eab-393de388da71 | 2026-02-20 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | fa7dd488-de7e-4f9e-87db-18391b723aad | 2026-02-19 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 394b1006-c160-4668-8684-82d1c4481202 | 2026-02-12 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 8e11401b-f5c2-42ac-ba63-2e71b5626b7e | 2026-02-12 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 4520fae0-acce-47a0-af9e-f4f16ea6b268 | 2026-02-12 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 2ce47caf-6ece-429c-b5d7-c47ba6952800 | 2026-02-12 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 99df68ea-4de7-4825-a6d7-894c70d01c28 | 2026-02-10 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 4f26f9dc-cf49-4b55-a6f7-f2f579893ee4 | 2026-02-10 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 2b737395-0238-400b-95ff-890b95c98425 | 2026-02-06 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | ASCLEMED USA INC. | 42a26f8a-dc67-42e4-abb0-d2602afb1b7d | 2026-02-06 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 1ac29774-2b53-4a3f-97fa-16c2880a0868 | 2026-02-06 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | b717aff6-f754-458d-be87-d12d87c5da00 | 2026-02-02 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | A-S Medication Solutions | 62de26a8-d6fc-463f-abe6-4656228c3142 | 2026-02-02 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| EUTHYROX | LEVOTHYROXINE SODIUM | Provell Pharmaceuticals, LLC | bc3c6830-ba68-4ba3-9896-a12d0ad0b275 | 2026-01-27 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Northwind Health Company, LLC | ffc34bc6-5de5-addb-e053-6294a90a25be | 2026-01-26 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.