Application 062373
- Type
- ANDA
- Sponsor
- BAXTER HLTHCARE
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 80MG BASE/100ML | No | No |
| 003 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 40MG BASE/100ML | No | No |
| 004 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 60MG BASE/100ML | No | No |
| 005 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 100MG BASE/100ML | No | No |
| 006 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 120MG BASE/100ML | No | Yes |
| 007 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 1.2MG BASE/ML | No | No |
| 008 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 1.6MG BASE/ML | No | No |
| 009 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 2MG BASE/ML | No | Yes |
| 010 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 2.4MG BASE/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A062373-001 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 0.8MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | ||
| A062373-002 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 80MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | ||
| A062373-003 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 40MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | ||
| A062373-004 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 60MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | ||
| A062373-005 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 100MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | ||
| A062373-006 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 120MG BASE/100ML | INJECTABLE / INJECTION | RS | 1982-09-07 | |
| A062373-007 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 1.2MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | ||
| A062373-008 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 1.6MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | ||
| A062373-009 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | RS | 1982-09-07 | |
| A062373-010 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 2.4MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 |
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 | A062373-001 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 0.8MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062373-002 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 80MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062373-003 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 40MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062373-004 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 60MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062373-005 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 100MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062373-006 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 120MG BASE/100ML | INJECTABLE / INJECTION | RS | 1982-09-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A062373-007 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 1.2MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062373-008 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 1.6MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062373-009 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 2MG BASE/ML | INJECTABLE / INJECTION | RS | 1982-09-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A062373-010 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 2.4MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062373-001 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 0.8MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062373-002 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 80MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062373-003 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 40MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062373-004 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 60MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062373-005 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 100MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062373-006 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 120MG BASE/100ML | INJECTABLE / INJECTION | RS | 1982-09-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A062373-007 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 1.2MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062373-008 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 1.6MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062373-009 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 2MG BASE/ML | INJECTABLE / INJECTION | RS | 1982-09-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A062373-010 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 2.4MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062373-001 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 0.8MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062373-002 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 80MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062373-003 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 40MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062373-004 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 60MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062373-005 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 100MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062373-006 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 120MG BASE/100ML | INJECTABLE / INJECTION | RS | 1982-09-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A062373-007 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 1.2MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062373-008 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 1.6MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062373-009 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 2MG BASE/ML | INJECTABLE / INJECTION | RS | 1982-09-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A062373-010 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 2.4MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062373-001 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 0.8MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062373-002 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 80MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062373-003 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 40MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062373-004 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 60MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062373-005 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 100MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062373-006 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 120MG BASE/100ML | INJECTABLE / INJECTION | RS | 1982-09-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062373-007 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 1.2MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062373-008 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 1.6MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062373-009 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 2MG BASE/ML | INJECTABLE / INJECTION | RS | 1982-09-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062373-010 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 2.4MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | 31067a03dcf5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062373-002 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062373-005 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062373-007 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062373-008 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A062373-002 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A062373-005 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A062373-007 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A062373-008 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062373-002 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062373-005 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062373-007 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062373-008 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A062373-002 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A062373-005 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A062373-007 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A062373-008 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A062373-002 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A062373-005 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A062373-007 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A062373-008 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A062373-002 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A062373-005 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A062373-007 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A062373-008 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A062373-002 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A062373-005 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A062373-007 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A062373-008 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A062373-002 | AP | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A062373-005 | AP | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A062373-007 | AP | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A062373-008 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A062373-002 | AP | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A062373-005 | AP | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A062373-007 | AP | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A062373-008 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A062373-002 | AP | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A062373-005 | AP | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A062373-007 | AP | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A062373-008 | AP | 1 | 5aa47cf7b7d7… |
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 in Sodium Chloride | GENTAMICIN SULFATE | Baxter Healthcare Corporation | 449c9a41-d61e-49fd-b5e3-d76f74b92acf | 2023-01-26 | Boxed warning, Warnings, Adverse reactions | 062373 ANDA062373 0338-0507 0338-0503 0338-0505 0338-0509 0338-0511 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0338-0503 | Gentamicin Sulfate in Sodium Chloride | Gentamicin Sulfate | Baxter Healthcare Corporation | ANDA | Current |
| 0338-0503 | Gentamicin Sulfate in Sodium Chloride | Gentamicin Sulfate | Baxter Healthcare Corporation | ANDA | Current |
| 0338-0503 | Gentamicin Sulfate in Sodium Chloride | Gentamicin Sulfate | Baxter Healthcare Corporation | ANDA | Current |
| 0338-0503 | Gentamicin Sulfate in Sodium Chloride | Gentamicin Sulfate | Baxter Healthcare Corporation | ANDA | Current |
| 0338-0505 | Gentamicin Sulfate in Sodium Chloride | Gentamicin Sulfate | Baxter Healthcare Corporation | ANDA | Current |
| 0338-0505 | Gentamicin Sulfate in Sodium Chloride | Gentamicin Sulfate | Baxter Healthcare Corporation | ANDA | Current |
| 0338-0505 | Gentamicin Sulfate in Sodium Chloride | Gentamicin Sulfate | Baxter Healthcare Corporation | ANDA | Current |
| 0338-0505 | Gentamicin Sulfate in Sodium Chloride | Gentamicin Sulfate | Baxter Healthcare Corporation | ANDA | Current |
| 0338-0507 | Gentamicin Sulfate in Sodium Chloride | Gentamicin Sulfate | Baxter Healthcare Corporation | ANDA | Current |
| 0338-0507 | Gentamicin Sulfate in Sodium Chloride | Gentamicin Sulfate | Baxter Healthcare Corporation | ANDA | Current |
| 0338-0507 | Gentamicin Sulfate in Sodium Chloride | Gentamicin Sulfate | Baxter Healthcare Corporation | ANDA | Current |
| 0338-0507 | Gentamicin Sulfate in Sodium Chloride | Gentamicin Sulfate | Baxter Healthcare Corporation | ANDA | Current |
| 0338-0509 | Gentamicin Sulfate in Sodium Chloride | Gentamicin Sulfate | Baxter Healthcare Corporation | ANDA | Current |
| 0338-0509 | Gentamicin Sulfate in Sodium Chloride | Gentamicin Sulfate | Baxter Healthcare Corporation | ANDA | Current |
| 0338-0509 | Gentamicin Sulfate in Sodium Chloride | Gentamicin Sulfate | Baxter Healthcare Corporation | ANDA | Current |
| 0338-0509 | Gentamicin Sulfate in Sodium Chloride | Gentamicin Sulfate | Baxter Healthcare Corporation | ANDA | Current |
| 0338-0511 | Gentamicin Sulfate in Sodium Chloride | Gentamicin Sulfate | Baxter Healthcare Corporation | ANDA | Current |
| 0338-0511 | Gentamicin Sulfate in Sodium Chloride | Gentamicin Sulfate | Baxter Healthcare Corporation | ANDA | Current |
| 0338-0511 | Gentamicin Sulfate in Sodium Chloride | Gentamicin Sulfate | Baxter Healthcare Corporation | ANDA | Current |
| 0338-0511 | Gentamicin Sulfate in Sodium Chloride | Gentamicin Sulfate | Baxter Healthcare Corporation | ANDA | Current |