Application 090291
- Type
- ANDA
- Sponsor
- FOSUN PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFEPIME HYDROCHLORIDE | CEFEPIME HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No |
| 002 | CEFEPIME HYDROCHLORIDE | CEFEPIME HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No |
| 003 | CEFEPIME HYDROCHLORIDE | CEFEPIME HYDROCHLORIDE | 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 |
|---|---|---|---|---|---|---|---|
| A090291-001 | CEFEPIME HYDROCHLORIDE | CEFEPIME HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | ||
| A090291-002 | CEFEPIME HYDROCHLORIDE | CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | ||
| A090291-003 | CEFEPIME HYDROCHLORIDE | CEFEPIME HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A090291-001 | CEFEPIME HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090291-002 | CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090291-003 | CEFEPIME HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090291-001 | CEFEPIME HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090291-002 | CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090291-003 | CEFEPIME HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090291-001 | CEFEPIME HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090291-002 | CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090291-003 | CEFEPIME HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090291-001 | CEFEPIME HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090291-002 | CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090291-003 | CEFEPIME HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090291-001 | CEFEPIME HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090291-002 | CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090291-003 | CEFEPIME HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090291-001 | CEFEPIME HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090291-002 | CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090291-003 | CEFEPIME HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090291-001 | CEFEPIME HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090291-002 | CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090291-003 | CEFEPIME HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090291-001 | CEFEPIME HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090291-002 | CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090291-003 | CEFEPIME HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090291-001 | CEFEPIME HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090291-002 | CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090291-003 | CEFEPIME HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090291-001 | CEFEPIME HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090291-002 | CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090291-003 | CEFEPIME HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090291-001 | CEFEPIME HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090291-002 | CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090291-003 | CEFEPIME HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090291-001 | CEFEPIME HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090291-002 | CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090291-003 | CEFEPIME HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090291-001 | CEFEPIME HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090291-002 | CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090291-003 | CEFEPIME HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090291-001 | CEFEPIME HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 8072bd15b7f6… |
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 |
|---|---|---|---|---|---|---|
| CEFEPIME HYDROCHLORIDE AND DEXTROSE | CEFEPIME HYDROCHLORIDE | B. Braun Medical Inc. | 57517a0e-ec1b-4605-a7cc-7e3801158ec9 | 2026-04-07 | Warnings, Adverse reactions | CEFEPIME HYDROCHLORIDE |
| Cefepime Hydrochloride | CEFEPIME HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | b9914e7e-13f6-42d4-9cbb-8c7ed1ce7a01 | 2025-10-14 | Warnings, Adverse reactions | Cefepime Hydrochloride CEFEPIME HYDROCHLORIDE |
| Cefepime Hydrochloride | CEFEPIME HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | f64c181e-28c5-48ab-aa67-5ca0e3fd079c | 2025-06-30 | Warnings, Adverse reactions | Cefepime Hydrochloride CEFEPIME HYDROCHLORIDE |
| Cefepime | CEFEPIME HYDROCHLORIDE | Qilu Pharmaceutical Co., Ltd. | 80b4c811-4a71-47fb-8565-85ce9d0f782c | 2021-11-15 | Warnings, Adverse reactions | CEFEPIME HYDROCHLORIDE |
| cefepime | CEFEPIME HYDROCHLORIDE | Sagent Pharmaceuticals | de477f37-40f6-4295-ae72-a2ee36a8922e | 2021-09-29 | Warnings, Adverse reactions | CEFEPIME HYDROCHLORIDE |