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 | Redpharm drug | fa1bbb6e-ed15-07c9-e053-6294a90aa4a0 | 2025-01-23 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Redpharm drug | fa2aebcd-3cd8-5128-e053-6294a90ac612 | 2025-01-23 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | Direct Rx | dd032289-acee-49fc-e053-2a95a90a5999 | 2025-01-22 | Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| levothyroxine sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | fc803107-aaa2-4753-ab97-7b4ed5cf4be5 | 2025-01-21 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | ddec2148-f97e-4a79-9943-4bef2386a7f2 | 2025-01-21 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals Inc. | 7ade3f9e-e3d2-401b-a6b7-aa4c9d1c9861 | 2025-01-20 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Direct_rx | 2b4bbe49-4bd0-ba16-e063-6394a90acefc | 2025-01-09 | Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Direct_Rx | 2b361866-e981-567c-e063-6294a90a5a5c | 2025-01-08 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | NuCare Pharmaceuticals, Inc. | 27e98e6d-9fd7-3a94-e063-6394a90a1dcb | 2024-12-24 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Proficient Rx LP | 576dcd01-d151-42ac-acd1-480a13bae176 | 2024-12-23 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | NuCare Pharmaceuticals,Inc. | 29bb8dbe-f8ba-e2ba-e063-6394a90af38c | 2024-12-20 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals Inc. | a0ffe111-3574-4481-a732-b68a7d58ef71 | 2024-12-17 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Preferred Pharmaceuticals Inc. | a55e735f-a5b0-4b85-9fd7-3a4b6723a81b | 2024-12-17 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 893f9d10-7ce5-4ae6-8f03-dfde35ca6c30 | 2024-12-11 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | f23cacf6-0509-4e6b-bb59-6f1c17b16411 | 2024-12-11 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 6edb9499-b869-4ec8-82d7-56d267fd3dec | 2024-12-11 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 2ee67e24-d72f-4419-a7d2-95bb44d9dd26 | 2024-12-11 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | b57d0cc5-9fc7-496a-9bfa-417a288bb825 | 2024-12-11 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | 68a6702d-ca0b-4e04-88a6-4accc8fb459e | 2024-12-11 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
| Levothyroxine sodium | LEVOTHYROXINE SODIUM | Bryant Ranch Prepack | e1f77539-2156-4890-baca-8b13779c745c | 2024-12-10 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.