Application 065072
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFOTAXIME | CEFOTAXIME SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | Yes |
| 002 | CEFOTAXIME | CEFOTAXIME SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | Yes |
| 003 | CEFOTAXIME | CEFOTAXIME SODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065072-001 | CEFOTAXIME | CEFOTAXIME SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | ||
| A065072-002 | CEFOTAXIME | CEFOTAXIME SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | ||
| A065072-003 | CEFOTAXIME | CEFOTAXIME SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A065072-001 | CEFOTAXIME | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A065072-002 | CEFOTAXIME | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A065072-003 | CEFOTAXIME | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A065072-001 | CEFOTAXIME | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A065072-002 | CEFOTAXIME | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A065072-003 | CEFOTAXIME | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A065072-001 | CEFOTAXIME | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A065072-002 | CEFOTAXIME | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A065072-003 | CEFOTAXIME | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065072-001 | CEFOTAXIME | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065072-002 | CEFOTAXIME | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065072-003 | CEFOTAXIME | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A065072-001 | CEFOTAXIME | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A065072-002 | CEFOTAXIME | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A065072-003 | CEFOTAXIME | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065072-001 | CEFOTAXIME | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065072-002 | CEFOTAXIME | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065072-003 | CEFOTAXIME | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065072-001 | CEFOTAXIME | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065072-002 | CEFOTAXIME | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065072-003 | CEFOTAXIME | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065072-001 | CEFOTAXIME | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065072-002 | CEFOTAXIME | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065072-003 | CEFOTAXIME | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065072-001 | CEFOTAXIME | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065072-002 | CEFOTAXIME | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065072-003 | CEFOTAXIME | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065072-001 | CEFOTAXIME | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065072-002 | CEFOTAXIME | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065072-003 | CEFOTAXIME | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065072-001 | CEFOTAXIME | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065072-002 | CEFOTAXIME | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065072-003 | CEFOTAXIME | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A065072-001 | CEFOTAXIME | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A065072-002 | CEFOTAXIME | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A065072-003 | CEFOTAXIME | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065072-001 | CEFOTAXIME | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065072-002 | CEFOTAXIME | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065072-003 | CEFOTAXIME | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065072-001 | CEFOTAXIME | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2002-11-20 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A065072-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065072-002 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065072-003 | AP | 1 | 74a2ff9319b5… |
| 2019-09-15 20:21 UTC | 2019-09 | A065072-001 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A065072-002 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A065072-003 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A065072-001 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A065072-002 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A065072-003 | AP | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Cefotaxime | CEFOTAXIME | Hikma Pharmaceuticals USA Inc. | ed23b6bc-32c7-4c50-a53d-313ae78e5623 | 2024-04-11 | Warnings, Adverse reactions | 065072 ANDA065072 0143-9931 0143-9930 0143-9933 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0143-9930 | Cefotaxime | Cefotaxime | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9930 | Cefotaxime | Cefotaxime | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9931 | Cefotaxime | Cefotaxime | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9931 | Cefotaxime | Cefotaxime | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9933 | Cefotaxime | Cefotaxime | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9933 | Cefotaxime | Cefotaxime | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 22309 | ORIG | 2005-07-22 |