Application 062655
- Type
- ANDA
- Sponsor
- LILLY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TAZIDIME | CEFTAZIDIME | INJECTABLE;INJECTION | 1GM/VIAL | No | No |
| 002 | TAZIDIME | CEFTAZIDIME | INJECTABLE;INJECTION | 2GM/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A062655-001 | TAZIDIME | CEFTAZIDIME | 1GM/VIAL | INJECTABLE / INJECTION | 1985-11-20 | ||
| A062655-002 | TAZIDIME | CEFTAZIDIME | 2GM/VIAL | INJECTABLE / INJECTION | 1985-11-20 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | A062655-001 | TAZIDIME | 1GM/VIAL | INJECTABLE / INJECTION | 1985-11-20 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A062655-002 | TAZIDIME | 2GM/VIAL | INJECTABLE / INJECTION | 1985-11-20 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A062655-001 | TAZIDIME | 1GM/VIAL | INJECTABLE / INJECTION | 1985-11-20 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A062655-002 | TAZIDIME | 2GM/VIAL | INJECTABLE / INJECTION | 1985-11-20 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A062655-001 | TAZIDIME | 1GM/VIAL | INJECTABLE / INJECTION | 1985-11-20 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A062655-002 | TAZIDIME | 2GM/VIAL | INJECTABLE / INJECTION | 1985-11-20 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A062655-001 | TAZIDIME | 1GM/VIAL | INJECTABLE / INJECTION | 1985-11-20 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A062655-002 | TAZIDIME | 2GM/VIAL | INJECTABLE / INJECTION | 1985-11-20 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Ceftazidime | CEFTAZIDIME | Sagent Pharmaceuticals | 112c5457-8d71-49f5-b531-9761d7d38c93 | 2026-08-03 | Warnings, Adverse reactions | CEFTAZIDIME |
| TAZICEF | CEFTAZIDIME | Hospira, Inc. | 40d48c5d-650e-461b-a67b-7e65772d1b92 | 2026-05-04 | Warnings, Adverse reactions | CEFTAZIDIME |
| TAZICEF | CEFTAZIDIME | Hospira, Inc. | 1ab5ae3e-e303-4499-4c89-472d7cc1e46c | 2024-07-04 | Warnings, Adverse reactions | CEFTAZIDIME |
| Ceftazidime | CEFTAZIDIME | Sagent Pharmaceuticals | aec64360-8452-4987-a366-a5a4f8762ab6 | 2024-01-03 | Warnings, Adverse reactions | CEFTAZIDIME |
| Ceftazidime | CEFTAZIDIME | WG Critical Care, LLC | bcc81df2-20e3-4738-bfcf-301da883c1d9 | 2023-09-11 | Warnings, Adverse reactions | CEFTAZIDIME |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.