Application 216755
- Type
- NDA
- Sponsor
- SAPTALIS PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LIKMEZ | METRONIDAZOLE | SUSPENSION;ORAL | 500MG/5ML | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N216755-001 | LIKMEZ | METRONIDAZOLE | 500MG/5ML | SUSPENSION / ORAL | RLD, RS | 2023-09-22 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N216755-001 | 12257236 | 2039-01-16 | U-3169 | Drug product | 2025-04-16 |
| N216755-001 | 12257236 | 2039-01-16 | U-4163 | Drug product | 2025-04-16 |
| N216755-001 | 12257236 | 2039-01-16 | U-4164 | Drug product | 2025-04-16 |
| N216755-001 | 11541035 | 2039-10-04 | Drug product | 2023-10-18 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N216755-001 | LIKMEZ | 500MG/5ML | SUSPENSION / ORAL | RLD, RS | 2023-09-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216755-001 | LIKMEZ | 500MG/5ML | SUSPENSION / ORAL | RLD, RS | 2023-09-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216755-001 | LIKMEZ | 500MG/5ML | SUSPENSION / ORAL | RLD, RS | 2023-09-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216755-001 | LIKMEZ | 500MG/5ML | SUSPENSION / ORAL | RLD, RS | 2023-09-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216755-001 | LIKMEZ | 500MG/5ML | SUSPENSION / ORAL | RLD, RS | 2023-09-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216755-001 | LIKMEZ | 500MG/5ML | SUSPENSION / ORAL | RLD, RS | 2023-09-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216755-001 | LIKMEZ | 500MG/5ML | SUSPENSION / ORAL | RLD, RS | 2023-09-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216755-001 | LIKMEZ | 500MG/5ML | SUSPENSION / ORAL | RLD, RS | 2023-09-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216755-001 | LIKMEZ | 500MG/5ML | SUSPENSION / ORAL | RLD, RS | 2023-09-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216755-001 | LIKMEZ | 500MG/5ML | SUSPENSION / ORAL | RLD, RS | 2023-09-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216755-001 | LIKMEZ | 500MG/5ML | SUSPENSION / ORAL | RLD, RS | 2023-09-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N216755-001 | LIKMEZ | 500MG/5ML | SUSPENSION / ORAL | RLD, RS | 2023-09-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N216755-001 | LIKMEZ | 500MG/5ML | SUSPENSION / ORAL | RLD, RS | 2023-09-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N216755-001 | LIKMEZ | 500MG/5ML | SUSPENSION / ORAL | RLD, RS | 2023-09-22 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N216755-001 | LIKMEZ | 500MG/5ML | SUSPENSION / ORAL | RLD, RS | 2023-09-22 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N216755-001 | LIKMEZ | 500MG/5ML | SUSPENSION / ORAL | RLD, RS | 2023-09-22 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N216755-001 | LIKMEZ | 500MG/5ML | SUSPENSION / ORAL | RLD, RS | 2023-09-22 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N216755-001 | LIKMEZ | 500MG/5ML | SUSPENSION / ORAL | RLD, RS | 2023-09-22 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N216755-001 | LIKMEZ | 500MG/5ML | SUSPENSION / ORAL | RLD, RS | 2023-09-22 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N216755-001 | LIKMEZ | 500MG/5ML | SUSPENSION / ORAL | RLD, RS | 2023-09-22 | 9b2671bbb829… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N216755-001 | LIKMEZ | 500MG/5ML | SUSPENSION / ORAL | RLD, RS | 2023-09-22 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N216755-001 | 12257236 | 2039-01-16 | U-3169 | Drug product | 2025-04-16 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N216755-001 | 12257236 | 2039-01-16 | U-4163 | Drug product | 2025-04-16 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N216755-001 | 12257236 | 2039-01-16 | U-4164 | Drug product | 2025-04-16 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N216755-001 | 11541035 | 2039-10-04 | Drug product | 2023-10-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216755-001 | 12257236 | 2039-01-16 | U-3169 | Drug product | 2025-04-16 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216755-001 | 12257236 | 2039-01-16 | U-4163 | Drug product | 2025-04-16 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216755-001 | 12257236 | 2039-01-16 | U-4164 | Drug product | 2025-04-16 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216755-001 | 11541035 | 2039-10-04 | Drug product | 2023-10-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216755-001 | 12257236 | 2039-01-16 | U-3169 | Drug product | 2025-04-16 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216755-001 | 12257236 | 2039-01-16 | U-4163 | Drug product | 2025-04-16 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216755-001 | 12257236 | 2039-01-16 | U-4164 | Drug product | 2025-04-16 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216755-001 | 11541035 | 2039-10-04 | Drug product | 2023-10-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216755-001 | 12257236 | 2039-01-16 | U-3169 | Drug product | 2025-04-16 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216755-001 | 12257236 | 2039-01-16 | U-4163 | Drug product | 2025-04-16 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216755-001 | 12257236 | 2039-01-16 | U-4164 | Drug product | 2025-04-16 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216755-001 | 11541035 | 2039-10-04 | Drug product | 2023-10-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216755-001 | 11541035 | 2039-10-04 | Drug product | 2023-10-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216755-001 | 11541035 | 2039-10-04 | Drug product | 2023-10-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216755-001 | 11541035 | 2039-10-04 | Drug product | 2023-10-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216755-001 | 11541035 | 2039-10-04 | Drug product | 2023-10-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216755-001 | 11541035 | 2039-10-04 | Drug product | 2023-10-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216755-001 | 11541035 | 2039-10-04 | Drug product | 2023-10-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216755-001 | 11541035 | 2039-10-04 | Drug product | 2023-10-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N216755-001 | 11541035 | 2039-10-04 | Drug product | 2023-10-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N216755-001 | 11541035 | 2039-10-04 | Drug product | 2023-10-18 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N216755-001 | 11541035 | 2039-10-04 | Drug product | 2023-10-18 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N216755-001 | 11541035 | 2039-10-04 | Drug product | 2023-10-18 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N216755-001 | 11541035 | 2039-10-04 | Drug product | 2023-10-18 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N216755-001 | 11541035 | 2039-10-04 | Drug product | 2023-10-18 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N216755-001 | 11541035 | 2039-10-04 | Drug product | 2023-10-18 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N216755-001 | 11541035 | 2039-10-04 | Drug product | 2023-10-18 | a72a2bbeb626… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N216755-001 | 12257236 | 2039-01-16 | U-3169 | Drug product | 2025-04-16 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N216755-001 | 12257236 | 2039-01-16 | U-4163 | Drug product | 2025-04-16 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N216755-001 | 12257236 | 2039-01-16 | U-4164 | Drug product | 2025-04-16 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N216755-001 | 11541035 | 2039-10-04 | Drug product | 2023-10-18 | 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 |
|---|---|---|---|---|---|---|
| LIKMEZ | METRONIDAZOLE ORAL | Saptalis Pharmaceuticals, LLC | e20c14eb-5361-4a93-ab46-a7bd9aeb9b98 | 2025-04-18 | Boxed warning, Warnings, Adverse reactions | 216755 NDA216755 |
| LIKMEZ | METRONIDAZOLE ORAL | Kesin Pharma Corporation | 23927a8b-1641-4104-aa85-d7b7bf4ebb9d | 2024-12-30 | Boxed warning, Warnings, Adverse reactions | 216755 NDA216755 |