Application 062325
- Type
- ANDA
- Sponsor
- INTL MEDICATION
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GENTAMICIN | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 40MG BASE/ML | No | No |
| 003 | GENTAMICIN | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 1MG BASE/ML | No | No |
| 004 | GENTAMICIN | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 100MG BASE/100ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A062325-001 | GENTAMICIN | GENTAMICIN SULFATE | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| A062325-003 | GENTAMICIN | GENTAMICIN SULFATE | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 1982-06-23 | ||
| A062325-004 | GENTAMICIN | GENTAMICIN SULFATE | EQ 100MG BASE/100ML | INJECTABLE / INJECTION | 1982-06-23 |
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 | A062325-001 | GENTAMICIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062325-003 | GENTAMICIN | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 1982-06-23 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062325-004 | GENTAMICIN | EQ 100MG BASE/100ML | INJECTABLE / INJECTION | 1982-06-23 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062325-001 | GENTAMICIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062325-003 | GENTAMICIN | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 1982-06-23 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062325-004 | GENTAMICIN | EQ 100MG BASE/100ML | INJECTABLE / INJECTION | 1982-06-23 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062325-001 | GENTAMICIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062325-003 | GENTAMICIN | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 1982-06-23 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062325-004 | GENTAMICIN | EQ 100MG BASE/100ML | INJECTABLE / INJECTION | 1982-06-23 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062325-001 | GENTAMICIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062325-003 | GENTAMICIN | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 1982-06-23 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062325-004 | GENTAMICIN | EQ 100MG BASE/100ML | INJECTABLE / INJECTION | 1982-06-23 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062325-001 | GENTAMICIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062325-003 | GENTAMICIN | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 1982-06-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062325-004 | GENTAMICIN | EQ 100MG BASE/100ML | INJECTABLE / INJECTION | 1982-06-23 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062325-001 | GENTAMICIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062325-003 | GENTAMICIN | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 1982-06-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062325-004 | GENTAMICIN | EQ 100MG BASE/100ML | INJECTABLE / INJECTION | 1982-06-23 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062325-001 | GENTAMICIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062325-003 | GENTAMICIN | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 1982-06-23 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062325-004 | GENTAMICIN | EQ 100MG BASE/100ML | INJECTABLE / INJECTION | 1982-06-23 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062325-001 | GENTAMICIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062325-003 | GENTAMICIN | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 1982-06-23 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062325-004 | GENTAMICIN | EQ 100MG BASE/100ML | INJECTABLE / INJECTION | 1982-06-23 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062325-001 | GENTAMICIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062325-003 | GENTAMICIN | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 1982-06-23 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062325-004 | GENTAMICIN | EQ 100MG BASE/100ML | INJECTABLE / INJECTION | 1982-06-23 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062325-001 | GENTAMICIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062325-003 | GENTAMICIN | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 1982-06-23 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062325-004 | GENTAMICIN | EQ 100MG BASE/100ML | INJECTABLE / INJECTION | 1982-06-23 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062325-001 | GENTAMICIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062325-003 | GENTAMICIN | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 1982-06-23 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062325-004 | GENTAMICIN | EQ 100MG BASE/100ML | INJECTABLE / INJECTION | 1982-06-23 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A062325-001 | GENTAMICIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A062325-003 | GENTAMICIN | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 1982-06-23 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A062325-004 | GENTAMICIN | EQ 100MG BASE/100ML | INJECTABLE / INJECTION | 1982-06-23 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062325-001 | GENTAMICIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062325-003 | GENTAMICIN | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 1982-06-23 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062325-004 | GENTAMICIN | EQ 100MG BASE/100ML | INJECTABLE / INJECTION | 1982-06-23 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062325-001 | GENTAMICIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 301d65b070ca… |
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 |
|---|---|---|---|---|---|---|
| Gentamicin Sulfate | GENTAMICIN SULFATE | Sandoz Inc | a213fb9c-08ea-4f30-a6c9-93c7a9ba5280 | 2024-01-02 | Warnings, Adverse reactions | GENTAMICIN SULFATE |
| Gentamicin | GENTAMICIN | Fresenius Kabi USA, LLC | 8bdeef7f-ad8e-46e0-a872-e945eae51d68 | 2023-12-20 | Boxed warning, Warnings, Adverse reactions | Gentamicin |
| Gentamicin Sulfate | GENTAMICIN SULFATE | Cosette Pharmaceuticals, Inc. | 16474069-510b-0754-9d78-9bc0354f6549 | 2023-11-23 | Adverse reactions | GENTAMICIN SULFATE |
| Gentamicin Sulfate | GENTAMICIN SULFATE | Cosette Pharmaceuticals, Inc. | 9e550dc9-509e-da05-8a97-ecbd0f5dd633 | 2023-11-22 | Adverse reactions | GENTAMICIN SULFATE |
| Gentamicin | GENTAMICIN SULFATE | Medical Purchasing Solutions, LLC | 09cf88af-59da-f147-e063-6294a90aac99 | 2023-11-10 | Boxed warning, Warnings, Adverse reactions | Gentamicin GENTAMICIN SULFATE |
| Gentamicin | GENTAMICIN SULFATE | Fresenius Kabi USA, LLC | 0cce2238-28d3-4280-b520-ffc3067a2ffa | 2023-10-31 | Boxed warning, Warnings, Adverse reactions | Gentamicin GENTAMICIN SULFATE |
| Gentamicin | GENTAMICIN | Fresenius Kabi USA, LLC | be5b414e-d598-4721-80ee-5836156ad210 | 2023-10-24 | Boxed warning, Warnings, Adverse reactions | Gentamicin |
| Gentamicin | GENTAMICIN SULFATE | Fresenius Kabi USA, LLC | a73a5453-c091-43fd-aae2-d992152363b1 | 2023-10-20 | Boxed warning, Warnings, Adverse reactions | Gentamicin GENTAMICIN SULFATE |
| Gentamicin | GENTAMICIN | Hikma Pharmaceuticals USA Inc. | 51fffac8-fb6e-4f7f-b2de-440252781a42 | 2023-09-07 | Boxed warning, Warnings, Adverse reactions | Gentamicin |
| Gentamicin Sulfate | GENTAMICIN SULFATE | A-S Medication Solutions | 76fabcd6-4da3-49e3-85a1-ca4fac55a207 | 2023-05-08 | Warnings, Adverse reactions | GENTAMICIN SULFATE |
| Gentamicin Sulfate | GENTAMICIN SULFATE | Medical Purchasing Solutions, LLC | a8b15217-cccb-2260-e053-2995a90a709d | 2023-05-03 | Boxed warning, Warnings, Adverse reactions | GENTAMICIN SULFATE |
| Gentamicin Sulfate | GENTAMICIN SULFATE | Padagis Israel Pharmaceuticals Ltd | 4cfbe37e-11d6-46fc-b287-0561387b17b7 | 2023-01-31 | Adverse reactions | GENTAMICIN SULFATE |
| Gentamicin Sulfate in Sodium Chloride | GENTAMICIN SULFATE | Baxter Healthcare Corporation | 449c9a41-d61e-49fd-b5e3-d76f74b92acf | 2023-01-26 | Boxed warning, Warnings, Adverse reactions | GENTAMICIN SULFATE |
| Gentamicin Sulfate | GENTAMICIN SULFATE | Asclemed USA, Inc. | b59e49e0-640b-43c3-ad07-711d1bb154e9 | 2022-07-19 | Warnings, Adverse reactions | GENTAMICIN SULFATE |
| Gentamicin Sulfate | GENTAMICIN SULFATE | Proficient Rx LP | 3a6677a6-def5-443e-82bc-c185d41f03b7 | 2022-06-01 | Warnings, Adverse reactions | GENTAMICIN SULFATE |
| Gentamicin Sulfate | GENTAMICIN SULFATE | Asclemed USA, Inc. | a54e5c95-609d-4d66-9573-5d1ac78fa58f | 2022-03-04 | Warnings, Adverse reactions | GENTAMICIN SULFATE |
| Gentamicin Sulfate | GENTAMICIN SULFATE | Proficient Rx LP | cf4386ba-c62a-4ee8-ab59-1bb2e737a5da | 2021-05-01 | Adverse reactions | GENTAMICIN SULFATE |
| Gentak | GENTAMICIN SULFATE | Proficient Rx LP | aebfe247-cdf7-4acb-97b3-6d4341d7c815 | 2019-11-01 | Warnings, Adverse reactions | GENTAMICIN SULFATE |
| Gentamicin Sulfate | GENTAMICIN SULFATE | Proficient Rx LP | 2098faaa-7f60-4640-8c37-19456ebba653 | 2019-11-01 | Warnings, Adverse reactions | GENTAMICIN SULFATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.