Application 201654
- Type
- ANDA
- Sponsor
- HOSPIRA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A201654-001 | CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2016-02-03 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A201654-001 | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2016-02-03 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Cefazolin | CEFAZOLIN SODIUM | Baxter Healthcare Corporation | d91a8d13-99a0-4d87-88dc-71cbd37922b4 | 2025-12-10 | Warnings, Adverse reactions | CEFAZOLIN SODIUM |
| Cefazolin Sodium | CEFAZOLIN SODIUM | B. Braun Medical Inc. | 17f8f038-c204-4dab-80d7-6f7ac41ddbec | 2025-03-10 | Warnings, Adverse reactions | Cefazolin Sodium 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 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 |