Application 065329
- Type
- ANDA
- Sponsor
- ACS DOBFAR
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFTRIAXONE | CEFTRIAXONE SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No |
| 002 | CEFTRIAXONE | CEFTRIAXONE SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No |
| 003 | CEFTRIAXONE | CEFTRIAXONE SODIUM | 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 |
|---|---|---|---|---|---|---|---|
| A065329-001 | CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | |
| A065329-002 | CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | |
| A065329-003 | CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065329-001 | AP |
| A065329-002 | AP |
| A065329-003 | AP |
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 | A065329-001 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065329-002 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065329-003 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065329-001 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065329-002 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065329-003 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065329-001 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065329-002 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065329-003 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065329-001 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065329-002 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065329-003 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065329-001 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065329-002 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065329-003 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065329-001 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065329-002 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065329-003 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065329-001 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065329-002 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065329-003 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065329-001 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065329-002 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065329-003 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065329-001 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065329-002 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065329-003 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065329-001 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065329-002 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065329-003 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065329-001 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065329-002 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065329-003 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065329-001 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065329-002 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065329-003 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065329-001 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065329-002 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065329-003 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065329-001 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2008-07-24 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A065329-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065329-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065329-003 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065329-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065329-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065329-003 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065329-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065329-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065329-003 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065329-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065329-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065329-003 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065329-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065329-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065329-003 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065329-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065329-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065329-003 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065329-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065329-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065329-003 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065329-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065329-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065329-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065329-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065329-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065329-003 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065329-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065329-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065329-003 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065329-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065329-002 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065329-003 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065329-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065329-002 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065329-003 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065329-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065329-002 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065329-003 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065329-001 | AP | 1 | 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 |
|---|---|---|---|---|---|---|
| Ceftriaxone | CEFTRIAXONE | WG Critical Care, LLC | 7bed9b33-29e3-4f04-9766-43a21c7ad47a | 2026-01-07 | Warnings, Adverse reactions | 065329 ANDA065329 44567-701 44567-702 |
| Ceftriaxone | CEFTRIAXONE | WG Critical Care, LLC | befd73ff-cb3b-4543-8a8e-bdb9b7fc1ff0 | 2025-04-07 | Warnings, Adverse reactions | 065329 ANDA065329 44567-701 44567-700 44567-702 |
| ceftriaxone | CEFTRIAXONE | Sagent Pharmaceuticals | 5cf93bc5-9e4c-4734-bc02-c7d0ac071022 | 2023-11-08 | Warnings, Adverse reactions | 065329 ANDA065329 25021-107 25021-105 25021-106 |
| Ceftriaxone | CEFTRIAXONE | Fresenius Kabi USA, LLC | 7ea1db43-40fa-417b-8911-ae98092070a0 | 2023-09-30 | Warnings, Adverse reactions | 065329 ANDA065329 63323-346 63323-347 |
| Ceftriaxone | CEFTRIAXONE | Proficient Rx LP | fcf401df-bcdc-4773-a63b-9741c0f74b3d | 2022-11-01 | Warnings, Adverse reactions | 065329 ANDA065329 71205-593 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 25021-105 | Ceftriaxone | Ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-105 | ceftriaxone | ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-105 | ceftriaxone | ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-105 | Ceftriaxone | Ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-105 | Ceftriaxone | Ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-105 | Ceftriaxone | Ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-105 | Ceftriaxone | Ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-105 | ceftriaxone | ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-105 | ceftriaxone | ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-105 | ceftriaxone | ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-105 | Ceftriaxone | Ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-105 | ceftriaxone | ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-106 | Ceftriaxone | Ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-106 | ceftriaxone | ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-106 | ceftriaxone | ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-106 | Ceftriaxone | Ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-106 | Ceftriaxone | Ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-106 | Ceftriaxone | Ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-106 | Ceftriaxone | Ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-106 | Ceftriaxone | Ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-106 | ceftriaxone | ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-106 | ceftriaxone | ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-106 | ceftriaxone | ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-106 | Ceftriaxone | Ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-106 | ceftriaxone | ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-107 | Ceftriaxone | Ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-107 | ceftriaxone | ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-107 | ceftriaxone | ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-107 | Ceftriaxone | Ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-107 | Ceftriaxone | Ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-107 | Ceftriaxone | Ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-107 | Ceftriaxone | Ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-107 | Ceftriaxone | Ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-107 | ceftriaxone | ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-107 | ceftriaxone | ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-107 | ceftriaxone | ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-107 | Ceftriaxone | Ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 25021-107 | ceftriaxone | ceftriaxone | Sagent Pharmaceuticals | ANDA | Current |
| 44567-700 | Ceftriaxone | Ceftriaxone | WG Critical Care, LLC | ANDA | Current |
| 44567-700 | Ceftriaxone | Ceftriaxone | WG Critical Care, LLC | ANDA | Current |
| 44567-700 | Ceftriaxone | Ceftriaxone | WG Critical Care, LLC | ANDA | Current |
| 44567-700 | Ceftriaxone | Ceftriaxone | WG Critical Care, LLC | ANDA | Current |
| 44567-700 | Ceftriaxone | Ceftriaxone | WG Critical Care, LLC | ANDA | Current |
| 44567-700 | Ceftriaxone | Ceftriaxone | WG Critical Care, LLC | ANDA | Current |
| 44567-701 | Ceftriaxone | Ceftriaxone | WG Critical Care, LLC | ANDA | Current |
| 44567-701 | Ceftriaxone | Ceftriaxone | WG Critical Care, LLC | ANDA | Current |
| 44567-701 | Ceftriaxone | Ceftriaxone | WG Critical Care, LLC | ANDA | Current |
| 44567-701 | Ceftriaxone | Ceftriaxone | WG Critical Care, LLC | ANDA | Current |
| 44567-701 | Ceftriaxone | Ceftriaxone | WG Critical Care, LLC | ANDA | Current |
| 44567-701 | Ceftriaxone | Ceftriaxone | WG Critical Care, LLC | ANDA | Current |
| 44567-701 | Ceftriaxone | Ceftriaxone | WG Critical Care, LLC | ANDA | Current |
| 44567-702 | Ceftriaxone | Ceftriaxone | WG Critical Care, LLC | ANDA | Current |
| 44567-702 | Ceftriaxone | Ceftriaxone | WG Critical Care, LLC | ANDA | Current |
| 44567-702 | Ceftriaxone | Ceftriaxone | WG Critical Care, LLC | ANDA | Current |
| 44567-702 | Ceftriaxone | Ceftriaxone | WG Critical Care, LLC | ANDA | Current |
| 44567-702 | Ceftriaxone | Ceftriaxone | WG Critical Care, LLC | ANDA | Current |
| 44567-702 | Ceftriaxone | Ceftriaxone | WG Critical Care, LLC | ANDA | Current |
| 44567-702 | Ceftriaxone | Ceftriaxone | WG Critical Care, LLC | ANDA | Current |
| 63323-346 | Ceftriaxone | Ceftriaxone | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-346 | Ceftriaxone | Ceftriaxone | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-346 | Ceftriaxone | Ceftriaxone | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-347 | Ceftriaxone | Ceftriaxone | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-347 | Ceftriaxone | Ceftriaxone | Fresenius Kabi USA, LLC | ANDA | Current |
| 71205-593 | Ceftriaxone | Ceftriaxone | Proficient Rx LP | ANDA | Current |
| 71205-593 | Ceftriaxone | Ceftriaxone | Proficient Rx LP | ANDA | Current |
| 79144-101 | Easy-Ceft | Ceftriaxone | American Health RX, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44232 | ORIG | 2008-09-19 |