Application 062510
- Type
- ANDA
- Sponsor
- ROCHE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ROCEPHIN | CEFTRIAXONE SODIUM | INJECTABLE;INJECTION | EQ 250MG BASE/VIAL | No | No |
| 002 | ROCEPHIN | CEFTRIAXONE SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No |
| 003 | ROCEPHIN | CEFTRIAXONE SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A062510-001 | ROCEPHIN | CEFTRIAXONE SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | ||
| A062510-002 | ROCEPHIN | CEFTRIAXONE SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | ||
| A062510-003 | ROCEPHIN | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 |
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 | A062510-001 | ROCEPHIN | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062510-002 | ROCEPHIN | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062510-003 | ROCEPHIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062510-001 | ROCEPHIN | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062510-002 | ROCEPHIN | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062510-003 | ROCEPHIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062510-001 | ROCEPHIN | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062510-002 | ROCEPHIN | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062510-003 | ROCEPHIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062510-001 | ROCEPHIN | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062510-002 | ROCEPHIN | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062510-003 | ROCEPHIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062510-001 | ROCEPHIN | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062510-002 | ROCEPHIN | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062510-003 | ROCEPHIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062510-001 | ROCEPHIN | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062510-002 | ROCEPHIN | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062510-003 | ROCEPHIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062510-001 | ROCEPHIN | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062510-002 | ROCEPHIN | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062510-003 | ROCEPHIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062510-001 | ROCEPHIN | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062510-002 | ROCEPHIN | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062510-003 | ROCEPHIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062510-001 | ROCEPHIN | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062510-002 | ROCEPHIN | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062510-003 | ROCEPHIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062510-001 | ROCEPHIN | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062510-002 | ROCEPHIN | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062510-003 | ROCEPHIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062510-001 | ROCEPHIN | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062510-002 | ROCEPHIN | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062510-003 | ROCEPHIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A062510-001 | ROCEPHIN | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A062510-002 | ROCEPHIN | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A062510-003 | ROCEPHIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062510-001 | ROCEPHIN | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062510-002 | ROCEPHIN | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062510-003 | ROCEPHIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062510-001 | ROCEPHIN | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | 1985-03-12 | 301d65b070ca… |
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 |
|---|---|---|---|---|---|---|
| Ceftriaxone Sodium | CEFTRIAXONE SODIUM | Apotex Corp. | ac03a72c-0e35-40f9-b7fc-081badb5f19c | 2023-01-28 | Warnings, Adverse reactions | CEFTRIAXONE SODIUM |
| Ceftriaxone | CEFTRIAXONE SODIUM | Samson Medical Technologies, LLC | 5cd2d96f-83e5-4326-ae87-d0ede4ba493a | 2023-01-15 | Warnings, Adverse reactions | CEFTRIAXONE SODIUM |
| Ceftriaxone Sodium | CEFTRIAXONE SODIUM | Proficient Rx LP | a25ab5ea-c46d-4562-8f7e-0ccffc2ab069 | 2022-10-01 | Warnings, Adverse reactions | CEFTRIAXONE SODIUM |
| Ceftriaxone Sodium | CEFTRIAXONE SODIUM | Proficient Rx LP | 42ba7a9d-7d2b-4eac-af59-897151a8c924 | 2022-05-02 | Warnings, Adverse reactions | CEFTRIAXONE SODIUM |
| Ceftriaxone Sodium | CEFTRIAXONE SODIUM | Hospira, Inc | 9d1f630b-e759-4395-9d01-ddc90e4fea75 | 2022-03-09 | Warnings, Adverse reactions | CEFTRIAXONE SODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.