Application 020183
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | SOLUTION;INTRAPERITONEAL | 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | Yes | No |
| 002 | DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | SOLUTION;INTRAPERITONEAL | 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | Yes | No |
| 003 | DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | SOLUTION;INTRAPERITONEAL | 18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | Yes | No |
| 004 | DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | SOLUTION;INTRAPERITONEAL | 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020183-001 | DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 |
| N020183-002 | DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 |
| N020183-003 | DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | RLD | 1992-12-04 | |
| N020183-004 | DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N020183-001 | AT |
| N020183-002 | AT |
| N020183-004 | AT |
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 | N020183-001 | DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020183-002 | DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020183-003 | DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | 18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | RLD | 1992-12-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020183-004 | DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N020183-001 | DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020183-002 | DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020183-003 | DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | 18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | RLD | 1992-12-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020183-004 | DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N020183-001 | DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020183-002 | DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020183-003 | DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | 18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | RLD | 1992-12-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020183-004 | DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020183-001 | DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020183-002 | DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020183-003 | DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | 18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | RLD | 1992-12-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020183-004 | DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020183-001 | DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020183-002 | DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020183-003 | DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | 18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | RLD | 1992-12-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020183-004 | DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020183-001 | DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020183-002 | DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020183-003 | DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | 18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | RLD | 1992-12-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020183-004 | DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020183-001 | DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020183-002 | DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020183-003 | DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | 18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | RLD | 1992-12-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020183-004 | DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020183-001 | DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020183-002 | DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020183-003 | DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | 18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | RLD | 1992-12-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020183-004 | DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020183-001 | DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020183-002 | DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020183-003 | DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | 18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | RLD | 1992-12-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020183-004 | DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020183-001 | DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020183-002 | DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020183-003 | DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | 18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | RLD | 1992-12-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020183-004 | DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD | 1992-12-04 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-14 00:12 UTC | 2019-12 | N020183-004 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N020183-001 | AT | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N020183-002 | AT | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N020183-004 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N020183-001 | AT | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020183-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020183-002 | AT | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020183-004 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N020183-001 | AT | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | N020183-002 | AT | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | N020183-004 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N020183-001 | AT | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | N020183-002 | AT | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | N020183-004 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020183-001 | AT | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020183-002 | AT | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020183-004 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020183-001 | AT | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020183-002 | AT | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020183-004 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020183-001 | AT | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020183-002 | AT | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020183-004 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020183-001 | AT | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020183-002 | AT | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020183-004 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N020183-001 | AT | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | N020183-002 | AT | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | N020183-004 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N020183-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | N020183-002 | AT | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | N020183-004 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020183-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020183-002 | AT | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020183-004 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N020183-001 | AT | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | N020183-002 | AT | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | N020183-004 | AT | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N020183-001 | AT | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | N020183-002 | AT | 1 | e64feba35796… |
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 |
|---|---|---|---|---|---|---|
| DIANEAL Low Calcium with Dextrose | SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE | Vantive US Healthcare LLC | aa268d3f-7389-4f25-801f-5d4825495f08 | 2026-04-16 | Warnings, Adverse reactions | 020183 NDA020183 0941-0424 0941-0430 0941-0433 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0941-0424 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0424 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0424 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corpora | NDA | Current |
| 0941-0424 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0424 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0424 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0424 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0424 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0424 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0424 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0430 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0430 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0430 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corpora | NDA | Current |
| 0941-0430 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0430 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0430 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0430 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0430 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0430 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0430 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0433 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0433 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0433 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corpora | NDA | Current |
| 0941-0433 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0433 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0433 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0433 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0433 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0433 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0433 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 74450 | SUPPL | 2023-06-06 |
| 74449 | SUPPL | 2023-06-06 |
| 45072 | SUPPL | 2016-08-17 |
| 45140 | SUPPL | 2016-08-16 |
| 12305 | SUPPL | 2015-09-04 |
| 2149 | SUPPL | 2015-09-04 |
| 34350 | SUPPL | 2015-02-10 |
| 2148 | SUPPL | 2015-02-10 |
| 24544 | SUPPL | 2013-04-24 |
| 12304 | SUPPL | 2013-04-23 |
| 20528 | SUPPL | 2007-11-19 |
| 24543 | SUPPL | 2005-08-11 |
| 2147 | SUPPL | 2005-08-11 |