Application 062248
- Type
- ANDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | U-GENCIN | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 10MG BASE/ML | No | No |
| 002 | U-GENCIN | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 40MG BASE/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A062248-001 | U-GENCIN | GENTAMICIN SULFATE | EQ 10MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| A062248-002 | U-GENCIN | GENTAMICIN SULFATE | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A062248-001 | U-GENCIN | EQ 10MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062248-002 | U-GENCIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062248-001 | U-GENCIN | EQ 10MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062248-002 | U-GENCIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062248-001 | U-GENCIN | EQ 10MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062248-002 | U-GENCIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062248-001 | U-GENCIN | EQ 10MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062248-002 | U-GENCIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062248-001 | U-GENCIN | EQ 10MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062248-002 | U-GENCIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062248-001 | U-GENCIN | EQ 10MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062248-002 | U-GENCIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062248-001 | U-GENCIN | EQ 10MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062248-002 | U-GENCIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062248-001 | U-GENCIN | EQ 10MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062248-002 | U-GENCIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062248-001 | U-GENCIN | EQ 10MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062248-002 | U-GENCIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A062248-001 | U-GENCIN | EQ 10MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A062248-002 | U-GENCIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062248-001 | U-GENCIN | EQ 10MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062248-002 | U-GENCIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062248-001 | U-GENCIN | EQ 10MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062248-002 | U-GENCIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062248-001 | U-GENCIN | EQ 10MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062248-002 | U-GENCIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A062248-001 | U-GENCIN | EQ 10MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A062248-002 | U-GENCIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062248-001 | U-GENCIN | EQ 10MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062248-002 | U-GENCIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A062248-001 | U-GENCIN | EQ 10MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A062248-002 | U-GENCIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A062248-001 | U-GENCIN | EQ 10MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A062248-002 | U-GENCIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A062248-001 | U-GENCIN | EQ 10MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A062248-002 | U-GENCIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A062248-001 | U-GENCIN | EQ 10MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A062248-002 | U-GENCIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A062248-001 | U-GENCIN | EQ 10MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A062248-002 | U-GENCIN | EQ 40MG BASE/ML | INJECTABLE / INJECTION | Approved before 1982 | 782e0a99824c… |
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 | Hospira, Inc. | 977180b3-a222-4282-d485-4a3217674305 | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | GENTAMICIN SULFATE |
| Gentamicin Sulfate | GENTAMICIN SULFATE | Cardinal Health 107, LLC | 5113bfad-42ca-4bb8-9343-0b08c6cd03f0 | 2026-05-08 | Boxed warning, Warnings, Adverse reactions | GENTAMICIN SULFATE |
| Gentamicin Sulfate | GENTAMICIN SULFATE | Preferred Pharmaceuticals Inc. | 5ac8ea7a-ee89-49f5-8d30-6dbb56503d94 | 2026-05-05 | Warnings, Adverse reactions | GENTAMICIN SULFATE |
| Gentamicin | GENTAMICIN SULFATE | Henry Schein, Inc | 84f6eb1c-a287-489a-8c3e-aa5954cf1992 | 2025-10-31 | Boxed warning, Warnings, Adverse reactions | GENTAMICIN SULFATE |
| Gentamicin Sulfate | GENTAMICIN SULFATE | Henry Schein, Inc. | 913a36c3-50d6-429a-a8dd-a03126d2ca08 | 2025-10-31 | Boxed warning, Warnings, Adverse reactions | GENTAMICIN SULFATE |
| Gentamicin Sulfate | GENTAMICIN SULFATE | Medical Purchasing Solutions, LLC | 3532bb39-a1a6-9d67-e063-6294a90abc0c | 2025-05-15 | Boxed warning, Warnings, Adverse reactions | GENTAMICIN SULFATE |
| Gentamicin Sulfate | GENTAMICIN SULFATE | Proficient Rx LP | 5193ed8d-44c9-46fe-924d-93aaea922cfd | 2025-05-01 | Warnings, Adverse reactions | GENTAMICIN SULFATE |
| Gentamicin Sulfate | GENTAMICIN SULFATE | NuCare Pharmaceuticals,Inc. | 0bef2a01-69d0-cf50-e063-6294a90a4c52 | 2025-02-03 | Warnings, Adverse reactions | GENTAMICIN SULFATE |
| Gentamicin | GENTAMICIN SULFATE | Fresenius Kabi USA, LLC | 84f5c763-1cd3-4d85-9afb-934db8666fbf | 2024-10-11 | Boxed warning, Warnings, Adverse reactions | GENTAMICIN SULFATE |
| Gentamicin Sulfate | GENTAMICIN SULFATE | NuCare Pharmaceuticals, Inc. | 4add8f7b-48f0-6b6a-e054-00144ff88e88 | 2024-08-14 | Warnings, Adverse reactions | GENTAMICIN SULFATE |
| Gentamicin Sulfate | GENTAMICIN SULFATE | Bausch & Lomb Incorporated | 41d01350-5c4b-42fc-be5f-986ceec02bd3 | 2024-07-22 | Warnings, Adverse reactions | GENTAMICIN SULFATE |
| Gentamicin Sulfate | GENTAMICIN SULFATE | NuCare Pharmaceuticals,Inc. | 82595309-304e-a221-e053-2991aa0ac0a9 | 2024-06-14 | Warnings, Adverse reactions | GENTAMICIN SULFATE |
| GENTAMICIN SULFATE | GENTAMICIN SULFATE | NuCare Pharmaceuticals,Inc. | 85424b40-5c2d-421d-e053-2991aa0a7771 | 2024-06-14 | Warnings, Adverse reactions | GENTAMICIN SULFATE |
| GENTAMICIN SULFATE | GENTAMICIN SULFATE | HF Acquisition Co LLC, DBA HealthFirst | e9fbe619-2afe-f1d7-e053-2a95a90aab29 | 2024-01-27 | Boxed warning, Warnings, Adverse reactions | GENTAMICIN SULFATE |
| Gentamicin Sulfate | GENTAMICIN SULFATE | Padagis Israel Pharmaceuticals Ltd | a9486ae1-350b-41c5-ae0c-a4d692bb2dfd | 2024-01-15 | Adverse reactions | GENTAMICIN SULFATE |
| gentamicin sulfate | GENTAMICIN SULFATE | DIRECT RX | 51a411a0-2671-4c1c-bf25-e29b32efed0c | 2024-01-10 | Warnings, Adverse reactions | GENTAMICIN SULFATE |
| Gentamicin Sulfate | GENTAMICIN SULFATE | Sandoz Inc | a213fb9c-08ea-4f30-a6c9-93c7a9ba5280 | 2024-01-02 | Warnings, Adverse reactions | GENTAMICIN SULFATE |
| 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 SULFATE |