Application 050821
- Type
- NDA
- Sponsor
- B BRAUN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | CEFEPIME HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No |
| 002 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | 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 |
|---|---|---|---|---|---|---|---|
| N050821-001 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS | 2010-05-06 | |
| N050821-002 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | CEFEPIME HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS | 2010-05-06 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N050821-001 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS | 2010-05-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050821-002 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS | 2010-05-06 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050821-001 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS | 2010-05-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050821-002 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS | 2010-05-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050821-001 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS | 2010-05-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050821-002 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS | 2010-05-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050821-001 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS | 2010-05-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050821-002 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS | 2010-05-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050821-001 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS | 2010-05-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050821-002 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS | 2010-05-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050821-001 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS | 2010-05-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050821-002 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS | 2010-05-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050821-001 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS | 2010-05-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050821-002 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS | 2010-05-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050821-001 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS | 2010-05-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050821-002 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS | 2010-05-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050821-001 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS | 2010-05-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050821-002 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS | 2010-05-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050821-001 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS | 2010-05-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050821-002 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS | 2010-05-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050821-001 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS | 2010-05-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050821-002 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS | 2010-05-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050821-001 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS | 2010-05-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050821-002 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS | 2010-05-06 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050821-001 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-05-06 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050821-002 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2010-05-06 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050821-001 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-05-06 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050821-002 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2010-05-06 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N050821-001 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-05-06 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N050821-002 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2010-05-06 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050821-001 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-05-06 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050821-002 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2010-05-06 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N050821-001 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-05-06 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N050821-002 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2010-05-06 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N050821-001 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-05-06 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N050821-002 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2010-05-06 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N050821-001 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-05-06 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N050821-002 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2010-05-06 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N050821-001 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-05-06 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N050821-002 | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | 2010-05-06 | bb7c543d1eb4… |
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 | 050821 NDA050821 0264-3193 0264-3195 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0264-3193 | CEFEPIME HYDROCHLORIDE AND DEXTROSE | CEFEPIME HYDROCHLORIDE | B. Braun Medical Inc. | NDA | Current |
| 0264-3193 | CEFEPIME HYDROCHLORIDE AND DEXTROSE | CEFEPIME HYDROCHLORIDE | B. Braun Medical Inc. | NDA | Current |
| 0264-3195 | CEFEPIME HYDROCHLORIDE AND DEXTROSE | CEFEPIME HYDROCHLORIDE | B. Braun Medical Inc. | NDA | Current |
| 0264-3195 | CEFEPIME HYDROCHLORIDE AND DEXTROSE | CEFEPIME HYDROCHLORIDE | B. Braun Medical Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85666 | SUPPL | 2026-04-10 |
| 85655 | SUPPL | 2026-04-09 |
| 70592 | SUPPL | 2022-03-24 |
| 70572 | SUPPL | 2022-03-21 |
| 39391 | SUPPL | 2015-11-13 |
| 8341 | SUPPL | 2015-11-13 |
| 39390 | SUPPL | 2014-06-10 |
| 30614 | SUPPL | 2014-06-10 |
| 39389 | SUPPL | 2012-09-11 |
| 8340 | SUPPL | 2012-09-10 |
| 42755 | ORIG | 2010-08-30 |
| 24350 | ORIG | 2010-08-30 |
| 18300 | ORIG | 2010-05-17 |
| 8339 | ORIG | 2010-05-10 |