Application 062989
- Type
- ANDA
- Sponsor
- DR REDDYS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | INJECTABLE;INJECTION | EQ 5GM BASE/VIAL | No | No |
| 002 | CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL | No | No |
| 003 | CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | INJECTABLE;INJECTION | EQ 20GM BASE/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A062989-001 | CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 5GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | ||
| A062989-002 | CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | ||
| A062989-003 | CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 20GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062989-002 | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062989-003 | CEFAZOLIN SODIUM | EQ 20GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062989-001 | CEFAZOLIN SODIUM | EQ 5GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062989-002 | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062989-003 | CEFAZOLIN SODIUM | EQ 20GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062989-001 | CEFAZOLIN SODIUM | EQ 5GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062989-002 | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062989-003 | CEFAZOLIN SODIUM | EQ 20GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A062989-001 | CEFAZOLIN SODIUM | EQ 5GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A062989-002 | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A062989-003 | CEFAZOLIN SODIUM | EQ 20GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062989-001 | CEFAZOLIN SODIUM | EQ 5GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062989-002 | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062989-003 | CEFAZOLIN SODIUM | EQ 20GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A062989-001 | CEFAZOLIN SODIUM | EQ 5GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A062989-002 | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A062989-003 | CEFAZOLIN SODIUM | EQ 20GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A062989-001 | CEFAZOLIN SODIUM | EQ 5GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A062989-002 | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A062989-003 | CEFAZOLIN SODIUM | EQ 20GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A062989-001 | CEFAZOLIN SODIUM | EQ 5GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A062989-002 | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A062989-003 | CEFAZOLIN SODIUM | EQ 20GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A062989-001 | CEFAZOLIN SODIUM | EQ 5GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A062989-002 | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A062989-003 | CEFAZOLIN SODIUM | EQ 20GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A062989-001 | CEFAZOLIN SODIUM | EQ 5GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A062989-002 | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A062989-003 | CEFAZOLIN SODIUM | EQ 20GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A062989-001 | CEFAZOLIN SODIUM | EQ 5GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A062989-002 | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A062989-003 | CEFAZOLIN SODIUM | EQ 20GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A062989-001 | CEFAZOLIN SODIUM | EQ 5GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A062989-002 | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A062989-003 | CEFAZOLIN SODIUM | EQ 20GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A062989-001 | CEFAZOLIN SODIUM | EQ 5GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A062989-002 | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A062989-003 | CEFAZOLIN SODIUM | EQ 20GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A062989-001 | CEFAZOLIN SODIUM | EQ 5GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A062989-002 | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | 1989-12-29 | c0c555d07b60… |
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 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.