Application 050461
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ANCEF | CEFAZOLIN SODIUM | INJECTABLE;INJECTION | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | ANCEF | CEFAZOLIN SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | Yes | No |
| 003 | ANCEF | CEFAZOLIN SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | ANCEF | CEFAZOLIN SODIUM | INJECTABLE;INJECTION | EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 005 | ANCEF | CEFAZOLIN SODIUM | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050461-001 | ANCEF | CEFAZOLIN SODIUM | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N050461-002 | ANCEF | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N050461-003 | ANCEF | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N050461-004 | ANCEF | CEFAZOLIN SODIUM | EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N050461-005 | ANCEF | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2021-03-12 10:30 UTC | 2021-03 | N050461-001 | ANCEF | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N050461-002 | ANCEF | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N050461-003 | ANCEF | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N050461-004 | ANCEF | EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N050461-005 | ANCEF | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N050461-001 | ANCEF | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N050461-002 | ANCEF | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N050461-003 | ANCEF | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N050461-004 | ANCEF | EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N050461-005 | ANCEF | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N050461-001 | ANCEF | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N050461-002 | ANCEF | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N050461-003 | ANCEF | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N050461-004 | ANCEF | EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N050461-005 | ANCEF | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N050461-001 | ANCEF | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N050461-002 | ANCEF | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N050461-003 | ANCEF | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N050461-004 | ANCEF | EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N050461-005 | ANCEF | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N050461-001 | ANCEF | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N050461-002 | ANCEF | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N050461-003 | ANCEF | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N050461-004 | ANCEF | EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N050461-005 | ANCEF | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N050461-001 | ANCEF | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N050461-002 | ANCEF | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N050461-003 | ANCEF | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N050461-004 | ANCEF | EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N050461-005 | ANCEF | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N050461-001 | ANCEF | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N050461-002 | ANCEF | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N050461-003 | ANCEF | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N050461-004 | ANCEF | EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N050461-005 | ANCEF | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N050461-001 | ANCEF | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N050461-002 | ANCEF | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N050461-003 | ANCEF | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N050461-004 | ANCEF | EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N050461-005 | ANCEF | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 1c564ffb4f44… |
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 |
|---|---|---|---|---|---|---|
| Cefazolin Sodium | CEFAZOLIN SODIUM | B. Braun Medical Inc. | 17f8f038-c204-4dab-80d7-6f7ac41ddbec | 2025-03-10 | Warnings, Adverse reactions | CEFAZOLIN SODIUM |
| CEFAZOLIN | CEFAZOLIN SODIUM | Samson Medical Technologies, L.L.C. | cf13db9c-d8a1-489f-9aa0-fc70839d4bbc | 2025-01-08 | Warnings, Adverse reactions | CEFAZOLIN SODIUM |
| Cefazolin Sodium | CEFAZOLIN SODIUM | Direct_rx | 22dfc2e4-07a7-8d13-e063-6394a90a3e9f | 2024-09-24 | Warnings, Adverse reactions | CEFAZOLIN SODIUM |
| CEFAZOLIN | CEFAZOLIN SODIUM | Fresenius Kabi USA, LLC | c47c8d14-1eef-40f9-9d11-f0c300b1d4be | 2023-09-27 | Warnings, Adverse reactions | CEFAZOLIN SODIUM |
| Cefazolin | CEFAZOLIN SODIUM | Fresenius Kabi USA, LLC | 47a8928f-708d-418a-829b-36eded96bac0 | 2020-06-17 | Boxed warning, Warnings, Adverse reactions | CEFAZOLIN SODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.