Application 210197
- Type
- ANDA
- Sponsor
- DEVA HOLDING AS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFTRIAXONE | CEFTRIAXONE SODIUM | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | EQ 250MG BASE/VIAL | No | No |
| 002 | CEFTRIAXONE | CEFTRIAXONE SODIUM | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | EQ 500MG BASE/VIAL | No | No |
| 003 | CEFTRIAXONE | CEFTRIAXONE SODIUM | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | EQ 1GM BASE/VIAL | No | No |
| 004 | CEFTRIAXONE | CEFTRIAXONE SODIUM | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | EQ 2GM BASE/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210197-001 | CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | ||
| A210197-002 | CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | ||
| A210197-003 | CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | ||
| A210197-004 | CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 |
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 | A210197-001 | CEFTRIAXONE | EQ 250MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A210197-002 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A210197-003 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A210197-004 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210197-001 | CEFTRIAXONE | EQ 250MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210197-002 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210197-003 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210197-004 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210197-001 | CEFTRIAXONE | EQ 250MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210197-002 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210197-003 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210197-004 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210197-001 | CEFTRIAXONE | EQ 250MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210197-002 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210197-003 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210197-004 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210197-001 | CEFTRIAXONE | EQ 250MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210197-002 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210197-003 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210197-004 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210197-001 | CEFTRIAXONE | EQ 250MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210197-002 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210197-003 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210197-004 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210197-001 | CEFTRIAXONE | EQ 250MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210197-002 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210197-003 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210197-004 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210197-001 | CEFTRIAXONE | EQ 250MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210197-002 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210197-003 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210197-004 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210197-001 | CEFTRIAXONE | EQ 250MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210197-002 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210197-003 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210197-004 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210197-001 | CEFTRIAXONE | EQ 250MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210197-002 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210197-003 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210197-004 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2024-01-12 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210197-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210197-002 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210197-003 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210197-004 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210197-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210197-002 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210197-003 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210197-004 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A210197-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A210197-002 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A210197-003 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A210197-004 | AP | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210197-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210197-002 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210197-003 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210197-004 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A210197-001 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A210197-002 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A210197-003 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A210197-004 | AP | 1 | 1c564ffb4f44… |
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 | Sportpharm LLC | ddbc3bf6-5bab-4851-ae5a-ef263cd8f255 | 2026-07-23 | Warnings, Adverse reactions | CEFTRIAXONE SODIUM |
| Ceftriaxone | CEFTRIAXONE | WG Critical Care, LLC | 86ec0a92-a552-4a6d-9125-a54f95e43392 | 2026-06-18 | Warnings, Adverse reactions | Ceftriaxone |
| Ceftriaxone Sodium | CEFTRIAXONE SODIUM | Sportpharm LLC | 85ce4f8b-77e0-48bf-9f57-93f1478befa2 | 2026-04-24 | Warnings, Adverse reactions | CEFTRIAXONE SODIUM |
| Ceftriaxone Sodium | CEFTRIAXONE SODIUM | Sportpharm LLC | 9a937e47-8c36-4656-83e1-b3c18ed9bac3 | 2026-04-24 | Warnings, Adverse reactions | CEFTRIAXONE SODIUM |
| Ceftriaxone Sodium | CEFTRIAXONE SODIUM | REMEDYREPACK INC. | 9c801096-ca61-4b29-a1e1-5f7e7813b191 | 2026-02-06 | Warnings, Adverse reactions | CEFTRIAXONE SODIUM |
| Ceftriaxone Sodium | CEFTRIAXONE SODIUM | Qilu Pharmaceutical Co., Ltd. | 4cdf0743-c62b-4969-b9c9-4c6400644f6c | 2026-02-04 | Warnings, Adverse reactions | CEFTRIAXONE SODIUM |
| Ceftriaxone Sodium | CEFTRIAXONE SODIUM | Hospira, Inc | 128bb292-d174-4769-b3e6-9f16617f31e3 | 2026-01-22 | Warnings, Adverse reactions | CEFTRIAXONE SODIUM |
| Ceftriaxone Sodium | CEFTRIAXONE SODIUM | Hospira, Inc | 19141ccd-e66c-49a2-a794-0616028495a7 | 2026-01-19 | Warnings, Adverse reactions | CEFTRIAXONE SODIUM |
| Ceftriaxone Sodium | CEFTRIAXONE SODIUM | Hospira, Inc | 03283208-8616-4117-9d2b-aa8046017a4f | 2026-01-19 | Warnings, Adverse reactions | CEFTRIAXONE SODIUM |
| Ceftriaxone Sodium | CEFTRIAXONE SODIUM | Hospira, Inc | 365fc265-8e6c-432f-9fda-911f5f7fb451 | 2026-01-16 | Warnings, Adverse reactions | CEFTRIAXONE SODIUM |
| Ceftriaxone Sodium | CEFTRIAXONE SODIUM | Hospira, Inc | 36c07ebf-b091-483e-b2c4-f0fc0c2b4186 | 2026-01-16 | Warnings, Adverse reactions | CEFTRIAXONE SODIUM |
| Ceftriaxone | CEFTRIAXONE | WG Critical Care, LLC | 7bed9b33-29e3-4f04-9766-43a21c7ad47a | 2026-01-07 | Warnings, Adverse reactions | Ceftriaxone |
| Ceftriaxone | CEFTRIAXONE | WG Critical Care, LLC | befd73ff-cb3b-4543-8a8e-bdb9b7fc1ff0 | 2025-04-07 | Warnings, Adverse reactions | Ceftriaxone |
| Ceftriaxone Sodium | CEFTRIAXONE SODIUM | Sandoz Inc | 53df951b-2eee-44b1-bae2-df7ed85bc0ed | 2025-02-28 | Warnings, Adverse reactions | CEFTRIAXONE SODIUM |
| Ceftriaxone Sodium | CEFTRIAXONE SODIUM | Sandoz Inc | de028434-46cf-44f6-8ac6-889c7c6943b3 | 2025-02-27 | Warnings, Adverse reactions | CEFTRIAXONE SODIUM |
| Ceftriaxone | CEFTRIAXONE SODIUM | Baxter Healthcare Company | 4c5c2d3f-5038-41a1-a2fe-4dcd048dbac1 | 2024-10-07 | Warnings, Adverse reactions | Ceftriaxone CEFTRIAXONE SODIUM |
| Ceftriaxone Sodium | CEFTRIAXONE SODIUM | A-S Medication Solutions | 53415af6-4072-4339-83e2-d870ae02a0e2 | 2024-08-20 | Warnings, Adverse reactions | CEFTRIAXONE SODIUM |
| Ceftriaxone Sodium | CEFTRIAXONE SODIUM | A-S Medication Solutions | b642877e-0d36-4218-afe9-0a39f35b571d | 2024-03-27 | Warnings, Adverse reactions | CEFTRIAXONE SODIUM |
| Ceftriaxone | CEFTRIAXONE | Civica, Inc. | 96f3fc1e-84f4-4e9b-91ac-19a1692f227a | 2024-02-06 | Warnings, Adverse reactions | Ceftriaxone |
| Ceftriaxone Sodium | CEFTRIAXONE SODIUM | Proficient Rx LP | 790279d4-2456-4091-abec-960b78885432 | 2024-02-01 | Warnings, Adverse reactions | CEFTRIAXONE SODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.