Application 062814
- Type
- ANDA
- Sponsor
- B BRAUN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 0.8MG BASE/ML | No | No |
| 002 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 1.2MG BASE/ML | No | No |
| 003 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 1.4MG BASE/ML | No | No |
| 004 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 1.6MG BASE/ML | No | No |
| 005 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 1.8MG BASE/ML | No | No |
| 006 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 2MG BASE/ML | No | No |
| 007 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 2.4MG BASE/ML | No | No |
| 008 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 40MG BASE/100ML | No | No |
| 009 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 60MG BASE/100ML | No | No |
| 010 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 70MG BASE/100ML | No | No |
| 011 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 80MG BASE/100ML | No | No |
| 012 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 90MG BASE/100ML | No | No |
| 013 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 100MG BASE/100ML | No | No |
| 014 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 120MG BASE/100ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A062814-001 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 0.8MG BASE/ML | INJECTABLE / INJECTION | 1987-08-28 | ||
| A062814-002 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 1.2MG BASE/ML | INJECTABLE / INJECTION | 1987-08-28 | ||
| A062814-003 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 1.4MG BASE/ML | INJECTABLE / INJECTION | 1987-08-28 | ||
| A062814-004 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 1.6MG BASE/ML | INJECTABLE / INJECTION | 1987-08-28 | ||
| A062814-005 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 1.8MG BASE/ML | INJECTABLE / INJECTION | 1987-08-28 | ||
| A062814-006 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 1987-08-28 | ||
| A062814-007 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 2.4MG BASE/ML | INJECTABLE / INJECTION | 1987-08-28 | ||
| A062814-008 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 40MG BASE/100ML | INJECTABLE / INJECTION | 1987-08-28 | ||
| A062814-009 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 60MG BASE/100ML | INJECTABLE / INJECTION | 1987-08-28 | ||
| A062814-010 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 70MG BASE/100ML | INJECTABLE / INJECTION | 1987-08-28 | ||
| A062814-011 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 80MG BASE/100ML | INJECTABLE / INJECTION | 1987-08-28 | ||
| A062814-012 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 90MG BASE/100ML | INJECTABLE / INJECTION | 1987-08-28 | ||
| A062814-013 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 100MG BASE/100ML | INJECTABLE / INJECTION | 1987-08-28 | ||
| A062814-014 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 120MG BASE/100ML | INJECTABLE / INJECTION | 1987-08-28 |
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 | A062814-001 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 0.8MG BASE/ML | INJECTABLE / INJECTION | 1987-08-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062814-002 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 1.2MG BASE/ML | INJECTABLE / INJECTION | 1987-08-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062814-003 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 1.4MG BASE/ML | INJECTABLE / INJECTION | 1987-08-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062814-004 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 1.6MG BASE/ML | INJECTABLE / INJECTION | 1987-08-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062814-005 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 1.8MG BASE/ML | INJECTABLE / INJECTION | 1987-08-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062814-006 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 1987-08-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062814-007 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 2.4MG BASE/ML | INJECTABLE / INJECTION | 1987-08-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062814-008 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 40MG BASE/100ML | INJECTABLE / INJECTION | 1987-08-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062814-009 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 60MG BASE/100ML | INJECTABLE / INJECTION | 1987-08-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062814-010 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 70MG BASE/100ML | INJECTABLE / INJECTION | 1987-08-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062814-011 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 80MG BASE/100ML | INJECTABLE / INJECTION | 1987-08-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062814-012 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 90MG BASE/100ML | INJECTABLE / INJECTION | 1987-08-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062814-013 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 100MG BASE/100ML | INJECTABLE / INJECTION | 1987-08-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062814-014 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 120MG BASE/100ML | INJECTABLE / INJECTION | 1987-08-28 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062814-001 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 0.8MG BASE/ML | INJECTABLE / INJECTION | 1987-08-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062814-002 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 1.2MG BASE/ML | INJECTABLE / INJECTION | 1987-08-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062814-003 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 1.4MG BASE/ML | INJECTABLE / INJECTION | 1987-08-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062814-004 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 1.6MG BASE/ML | INJECTABLE / INJECTION | 1987-08-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062814-005 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 1.8MG BASE/ML | INJECTABLE / INJECTION | 1987-08-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062814-006 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 1987-08-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062814-007 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 2.4MG BASE/ML | INJECTABLE / INJECTION | 1987-08-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062814-008 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 40MG BASE/100ML | INJECTABLE / INJECTION | 1987-08-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062814-009 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 60MG BASE/100ML | INJECTABLE / INJECTION | 1987-08-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062814-010 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 70MG BASE/100ML | INJECTABLE / INJECTION | 1987-08-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062814-011 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 80MG BASE/100ML | INJECTABLE / INJECTION | 1987-08-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062814-012 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 90MG BASE/100ML | INJECTABLE / INJECTION | 1987-08-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062814-013 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 100MG BASE/100ML | INJECTABLE / INJECTION | 1987-08-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062814-014 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 120MG BASE/100ML | INJECTABLE / INJECTION | 1987-08-28 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062814-001 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 0.8MG BASE/ML | INJECTABLE / INJECTION | 1987-08-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062814-002 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 1.2MG BASE/ML | INJECTABLE / INJECTION | 1987-08-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062814-003 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 1.4MG BASE/ML | INJECTABLE / INJECTION | 1987-08-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062814-004 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 1.6MG BASE/ML | INJECTABLE / INJECTION | 1987-08-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062814-005 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 1.8MG BASE/ML | INJECTABLE / INJECTION | 1987-08-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062814-006 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 2MG BASE/ML | INJECTABLE / INJECTION | 1987-08-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062814-007 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 2.4MG BASE/ML | INJECTABLE / INJECTION | 1987-08-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062814-008 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 40MG BASE/100ML | INJECTABLE / INJECTION | 1987-08-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062814-009 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 60MG BASE/100ML | INJECTABLE / INJECTION | 1987-08-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062814-010 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 70MG BASE/100ML | INJECTABLE / INJECTION | 1987-08-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062814-011 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 80MG BASE/100ML | INJECTABLE / INJECTION | 1987-08-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062814-012 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 90MG BASE/100ML | INJECTABLE / INJECTION | 1987-08-28 | 011fe1cb6892… |
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 | GENTAMICIN SULFATE | Fresenius Kabi USA, LLC | 0cce2238-28d3-4280-b520-ffc3067a2ffa | 2023-10-31 | Boxed warning, Warnings, Adverse reactions | GENTAMICIN SULFATE |
| Gentamicin | GENTAMICIN SULFATE | Fresenius Kabi USA, LLC | a73a5453-c091-43fd-aae2-d992152363b1 | 2023-10-20 | Boxed warning, Warnings, Adverse reactions | GENTAMICIN SULFATE |
| 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.