Application 061490
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXACILLIN SODIUM | OXACILLIN SODIUM | INJECTABLE;INJECTION | EQ 250MG BASE/VIAL | No | No |
| 002 | OXACILLIN SODIUM | OXACILLIN SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No |
| 003 | OXACILLIN SODIUM | OXACILLIN SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No |
| 004 | OXACILLIN SODIUM | OXACILLIN SODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | No | No |
| 006 | OXACILLIN SODIUM | OXACILLIN SODIUM | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A061490-001 | OXACILLIN SODIUM | OXACILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | ||
| A061490-002 | OXACILLIN SODIUM | OXACILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | ||
| A061490-003 | OXACILLIN SODIUM | OXACILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | ||
| A061490-004 | OXACILLIN SODIUM | OXACILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | ||
| A061490-006 | OXACILLIN SODIUM | OXACILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | 1991-05-09 |
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 | A061490-001 | OXACILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A061490-002 | OXACILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A061490-003 | OXACILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A061490-004 | OXACILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A061490-006 | OXACILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | 1991-05-09 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061490-001 | OXACILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061490-002 | OXACILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061490-003 | OXACILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061490-004 | OXACILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061490-006 | OXACILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | 1991-05-09 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A061490-001 | OXACILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A061490-002 | OXACILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A061490-003 | OXACILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A061490-004 | OXACILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A061490-006 | OXACILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | 1991-05-09 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061490-001 | OXACILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061490-002 | OXACILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061490-003 | OXACILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061490-004 | OXACILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061490-006 | OXACILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | 1991-05-09 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061490-001 | OXACILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061490-002 | OXACILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061490-003 | OXACILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061490-004 | OXACILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061490-006 | OXACILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | 1991-05-09 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061490-001 | OXACILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061490-002 | OXACILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061490-003 | OXACILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061490-004 | OXACILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061490-006 | OXACILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | 1991-05-09 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A061490-001 | OXACILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A061490-002 | OXACILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A061490-003 | OXACILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A061490-004 | OXACILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A061490-006 | OXACILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | 1991-05-09 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A061490-001 | OXACILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A061490-002 | OXACILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A061490-003 | OXACILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A061490-004 | OXACILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A061490-006 | OXACILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | 1991-05-09 | 5bbf6a4d5a75… |
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 |
|---|---|---|---|---|---|---|
| Oxacillin | OXACILLIN SODIUM | Eugia US LLC | 81e90279-9889-47bd-974b-334c181f295c | 2025-08-13 | Warnings, Adverse reactions | OXACILLIN SODIUM |
| Oxacillin | OXACILLIN SODIUM | Eugia US LLC | 152758c0-d225-4761-abeb-3f1cb0190806 | 2025-08-13 | Warnings, Adverse reactions | OXACILLIN SODIUM |
| Oxacillin | OXACILLIN SODIUM | Fresenius Kabi USA, LLC | 9d37aae5-78d6-4b72-832a-7152c3a7068e | 2020-07-31 | Warnings, Adverse reactions | OXACILLIN SODIUM |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0781-3099 | Oxacillin | Oxacillin | Sandoz Inc | ANDA | Current |
| 0781-3101 | Oxacillin | Oxacillin | Sandoz Inc | ANDA | Current |
| 0781-3103 | Oxacillin | Oxacillin | Sandoz Inc | ANDA | Current |
| 0781-9109 | Oxacillin | Oxacillin | Sandoz Inc | ANDA | Current |
| 0781-9111 | Oxacillin | Oxacillin | Sandoz Inc | ANDA | Current |
| 0781-9113 | Oxacillin | Oxacillin | Sandoz Inc | ANDA | Current |