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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | A090291-001 | CEFEPIME HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A090291-002 | CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A090291-003 | CEFEPIME HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A090291-001 | CEFEPIME HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A090291-002 | CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A090291-003 | CEFEPIME HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A090291-001 | CEFEPIME HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A090291-002 | CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A090291-003 | CEFEPIME HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A090291-001 | CEFEPIME HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A090291-002 | CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A090291-003 | CEFEPIME HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2010-12-21 | 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 |
|---|---|---|---|---|---|---|
| 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.