Application 050618
- Type
- NDA
- Sponsor
- APOTHECON
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | AMIKACIN SULFATE | INJECTABLE;INJECTION | EQ 10MG BASE/ML | No | No |
| 002 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | AMIKACIN SULFATE | INJECTABLE;INJECTION | EQ 5MG BASE/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050618-001 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | AMIKACIN SULFATE | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | ||
| N050618-002 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | AMIKACIN SULFATE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 |
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 | N050618-001 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050618-002 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050618-001 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050618-002 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050618-001 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050618-002 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050618-001 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050618-002 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050618-001 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050618-002 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050618-001 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050618-002 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050618-001 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050618-002 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050618-001 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050618-002 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050618-001 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050618-002 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050618-001 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050618-002 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050618-001 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050618-002 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N050618-001 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N050618-002 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050618-001 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050618-002 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050618-001 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050618-002 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050618-001 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050618-002 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N050618-001 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N050618-002 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050618-001 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050618-002 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N050618-001 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N050618-002 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N050618-001 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N050618-002 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N050618-001 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N050618-002 | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 1987-11-30 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| amikacin sulfate | AMIKACIN SULFATE | Sagent Pharmaceuticals | f260ff2a-76a0-4672-9516-91c344b67890 | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | AMIKACIN SULFATE |
| Amikacin Sulfate | AMIKACIN SULFATE | Mullan Pharmaceutical Inc. | 840ba25a-d60c-4f0d-a084-71b0c68237df | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | AMIKACIN SULFATE |
| Amikacin Sulfate | AMIKACIN SULFATE | Qilu Pharmaceutical Co., Ltd. | 20fa61ef-11e2-4d01-82ea-b5412cefaead | 2025-12-10 | Boxed warning, Warnings, Adverse reactions | AMIKACIN SULFATE |
| Amikacin Sulfate | AMIKACIN SULFATE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | a43188fa-f228-4acd-8a5d-9a3462034f4b | 2025-06-18 | Boxed warning, Warnings, Adverse reactions | AMIKACIN SULFATE |
| Amikacin Sulfate | AMIKACIN SULFATE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 7791d3e1-9287-4f75-b4f0-e5d35cacfd6e | 2024-06-28 | Boxed warning, Warnings, Adverse reactions | AMIKACIN SULFATE |
| Amikacin Sulfate | AMIKACIN SULFATE | Hikma Pharmaceuticals USA Inc. | 0b56f6df-a05d-4520-8bf0-d7cefe20f6ad | 2024-04-08 | Boxed warning, Warnings, Adverse reactions | AMIKACIN SULFATE |
| Amikacin Sulfate | AMIKACIN SULFATE | Fresenius Kabi USA, LLC | c0f57839-1c9b-49e5-8c7a-708e2d16495d | 2023-05-31 | Boxed warning, Warnings, Adverse reactions | AMIKACIN SULFATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.