Application 065197
- Type
- ANDA
- Sponsor
- WOCKHARDT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFOTAXIME | CEFOTAXIME SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No |
| 002 | CEFOTAXIME SODIUM | CEFOTAXIME SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No |
| 003 | CEFOTAXIME SODIUM | CEFOTAXIME SODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065197-001 | CEFOTAXIME | CEFOTAXIME SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2006-08-29 | ||
| A065197-002 | CEFOTAXIME SODIUM | CEFOTAXIME SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2008-06-20 | ||
| A065197-003 | CEFOTAXIME SODIUM | CEFOTAXIME SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2008-06-20 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065197-002 | CEFOTAXIME SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2008-06-20 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065197-003 | CEFOTAXIME SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2008-06-20 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065197-001 | CEFOTAXIME | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2006-08-29 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065197-002 | CEFOTAXIME SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2008-06-20 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065197-003 | CEFOTAXIME SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2008-06-20 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A065197-001 | CEFOTAXIME | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2006-08-29 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A065197-002 | CEFOTAXIME SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2008-06-20 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A065197-003 | CEFOTAXIME SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2008-06-20 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065197-001 | CEFOTAXIME | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2006-08-29 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065197-002 | CEFOTAXIME SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2008-06-20 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065197-003 | CEFOTAXIME SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2008-06-20 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A065197-001 | CEFOTAXIME | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2006-08-29 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A065197-002 | CEFOTAXIME SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2008-06-20 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A065197-003 | CEFOTAXIME SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2008-06-20 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A065197-001 | CEFOTAXIME | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2006-08-29 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A065197-002 | CEFOTAXIME SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2008-06-20 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A065197-003 | CEFOTAXIME SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2008-06-20 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A065197-001 | CEFOTAXIME | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2006-08-29 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065197-002 | CEFOTAXIME SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-06-20 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065197-003 | CEFOTAXIME SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-06-20 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065197-001 | CEFOTAXIME | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2006-08-29 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A065197-002 | CEFOTAXIME SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2008-06-20 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A065197-003 | CEFOTAXIME SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2008-06-20 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A065197-001 | CEFOTAXIME | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2006-08-29 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A065197-002 | CEFOTAXIME SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2008-06-20 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A065197-003 | CEFOTAXIME SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2008-06-20 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A065197-001 | CEFOTAXIME | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2006-08-29 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A065197-002 | CEFOTAXIME SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2008-06-20 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A065197-003 | CEFOTAXIME SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2008-06-20 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A065197-001 | CEFOTAXIME | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2006-08-29 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A065197-002 | CEFOTAXIME SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2008-06-20 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A065197-003 | CEFOTAXIME SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2008-06-20 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A065197-001 | CEFOTAXIME | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2006-08-29 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A065197-002 | CEFOTAXIME SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2008-06-20 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A065197-003 | CEFOTAXIME SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2008-06-20 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A065197-001 | CEFOTAXIME | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2006-08-29 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A065197-002 | CEFOTAXIME SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2008-06-20 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A065197-003 | CEFOTAXIME SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2008-06-20 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A065197-001 | CEFOTAXIME | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2006-08-29 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A065197-002 | CEFOTAXIME SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2008-06-20 | 3f01610625f2… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A065197-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065197-002 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065197-003 | AP | 1 | 74a2ff9319b5… |
| 2019-09-15 20:21 UTC | 2019-09 | A065197-001 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A065197-002 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A065197-003 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A065197-001 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A065197-002 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A065197-003 | 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 INJECTION | SteriMax Inc. | 8efe3bd0-c43a-2bd6-e053-2a95a90a92fa | 2026-06-15 | Cefotaxime | |
| Cefotaxime | CEFOTAXIME | Hikma Pharmaceuticals USA Inc. | ed23b6bc-32c7-4c50-a53d-313ae78e5623 | 2024-04-11 | Warnings, Adverse reactions | Cefotaxime |
| Cefotaxime | CEFOTAXIME | Hikma Pharmaceuticals USA Inc. | ef1a6dc6-bc3d-4f09-8f92-7ff328f56561 | 2024-04-11 | Warnings, Adverse reactions | Cefotaxime |
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 |
|---|---|---|---|---|---|
| 55648-947 | CEFOTAXIME | CEFOTAXIME | WOCKHARDT LIMITED | ANDA | Current |
| 55648-948 | CEFOTAXIME | CEFOTAXIME | WOCKHARDT LIMITED | ANDA | Current |
| 55648-986 | CEFOTAXIME | CEFOTAXIME | WOCKHARDT LIMITED | ANDA | Current |
| 64679-947 | Cefotaxime | Cefotaxime | Wockhardt USA LLC. | ANDA | Current |
| 64679-947 | Cefotaxime | Cefotaxime | Wockhardt USA LLC. | ANDA | Current |
| 64679-948 | Cefotaxime | Cefotaxime | Wockhardt USA LLC. | ANDA | Current |
| 64679-948 | Cefotaxime | Cefotaxime | Wockhardt USA LLC. | ANDA | Current |
| 64679-986 | Cefotaxime | Cefotaxime | Wockhardt USA LLC. | ANDA | Current |
| 64679-986 | Cefotaxime | Cefotaxime | Wockhardt USA LLC. | ANDA | Current |