Application 017512
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | SOLUTION;INTRAPERITONEAL | 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | No | No |
| 002 | DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | SOLUTION;INTRAPERITONEAL | 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | No | No |
| 003 | DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | SOLUTION;INTRAPERITONEAL | 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | No | No |
| 004 | DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | SOLUTION;INTRAPERITONEAL | 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | Yes | No |
| 005 | DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | SOLUTION;INTRAPERITONEAL | 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | Yes | No |
| 006 | DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | SOLUTION;INTRAPERITONEAL | 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | Yes | No |
| 007 | DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | SOLUTION;INTRAPERITONEAL | 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | No | No |
| 008 | DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | SOLUTION;INTRAPERITONEAL | 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | No | No |
| 009 | DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | SOLUTION;INTRAPERITONEAL | 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | No | No |
| 010 | DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | SOLUTION;INTRAPERITONEAL | 25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | No | No |
| 011 | DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | SOLUTION;INTRAPERITONEAL | 25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | Yes | No |
| 012 | 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 |
| 013 | 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 |
| 014 | 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 |
| 015 | 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 |
|---|---|---|---|---|---|---|---|
| N017512-001 | DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | Approved before 1982 | ||
| N017512-002 | DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | Approved before 1982 | ||
| N017512-003 | DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | Approved before 1982 | ||
| N017512-004 | DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, Approved before 1982 | |
| N017512-005 | DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, Approved before 1982 | |
| N017512-006 | DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, Approved before 1982 | |
| N017512-007 | DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1984-07-09 | ||
| N017512-008 | DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1984-07-09 | ||
| N017512-009 | DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1984-07-09 | ||
| N017512-010 | DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1985-11-18 | ||
| N017512-011 | DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | RLD | 1985-11-18 | |
| N017512-012 | 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 | 1989-01-10 |
| N017512-013 | 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 | 1990-07-11 |
| N017512-014 | 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 | 1990-07-11 | |
| N017512-015 | 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 | 1990-07-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N017512-004 | AT |
| N017512-005 | AT |
| N017512-006 | AT |
| N017512-012 | AT |
| N017512-013 | AT |
| N017512-015 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N017512-001 | DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017512-002 | DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017512-003 | DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017512-004 | DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017512-005 | DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017512-006 | DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017512-007 | DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1984-07-09 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017512-008 | DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1984-07-09 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017512-009 | DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1984-07-09 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017512-010 | DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | 25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1985-11-18 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017512-011 | DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | 25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | RLD | 1985-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017512-012 | 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 | 1989-01-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017512-013 | 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 | 1990-07-11 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017512-014 | 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 | 1990-07-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017512-015 | 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 | 1990-07-11 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-001 | DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-002 | DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-003 | DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-004 | DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-005 | DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-006 | DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-007 | DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1984-07-09 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-008 | DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1984-07-09 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-009 | DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1984-07-09 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-010 | DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | 25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1985-11-18 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-011 | DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | 25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | RLD | 1985-11-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-012 | 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 | 1989-01-10 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-013 | 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 | 1990-07-11 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-014 | 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 | 1990-07-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-015 | 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 | 1990-07-11 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N017512-001 | DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017512-002 | DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017512-003 | DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017512-004 | DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N017512-005 | DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N017512-006 | DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N017512-007 | DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1984-07-09 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017512-008 | DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1984-07-09 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017512-009 | DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1984-07-09 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017512-010 | DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | 25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | 1985-11-18 | 6a471c1ec25d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N017512-004 | AT | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017512-005 | AT | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017512-006 | AT | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017512-012 | AT | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017512-013 | AT | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017512-015 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-004 | AT | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-005 | AT | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-006 | AT | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-012 | AT | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-013 | AT | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017512-015 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N017512-004 | AT | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N017512-005 | AT | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N017512-006 | AT | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N017512-012 | AT | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N017512-013 | AT | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N017512-015 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017512-004 | AT | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017512-005 | AT | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017512-006 | AT | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017512-012 | AT | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017512-013 | AT | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017512-015 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017512-004 | AT | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017512-005 | AT | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017512-006 | AT | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017512-012 | AT | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017512-013 | AT | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017512-014 | AT | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017512-015 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017512-004 | AT | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017512-005 | AT | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017512-006 | AT | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017512-012 | AT | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017512-013 | AT | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017512-014 | AT | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017512-015 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017512-004 | AT | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017512-005 | AT | 1 | 2680178bc6a6… |
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 | 017512 NDA017512 0941-0411 0941-0487 0941-0484 0941-0415 0941-0459 0941-0457 0941-0413 0941-0409 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0941-0409 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0409 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0409 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corpora | NDA | Current |
| 0941-0409 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0409 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0409 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0409 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0409 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0409 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0409 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0411 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0411 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0411 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corpora | NDA | Current |
| 0941-0411 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0411 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0411 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0411 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0411 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0411 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0411 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0413 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0413 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0413 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corpora | NDA | Current |
| 0941-0413 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0413 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0413 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0413 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0413 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0413 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0413 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0415 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0415 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0415 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corpora | NDA | Current |
| 0941-0415 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0415 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0415 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0415 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0415 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0415 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0415 | DIANEAL PD-2 with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0457 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0457 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0457 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corpora | NDA | Current |
| 0941-0457 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0457 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0457 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0457 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0457 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0457 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0457 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0459 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0459 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0459 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corpora | NDA | Current |
| 0941-0459 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0459 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0459 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0459 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0459 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0459 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0459 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0484 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0484 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0484 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corpora | NDA | Current |
| 0941-0484 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0484 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0484 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0484 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0484 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0484 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0484 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0487 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0487 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0487 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corpora | NDA | Current |
| 0941-0487 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0487 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0487 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0487 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0487 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0487 | DIANEAL Low Calcium with Dextrose | sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose | Baxter Healthcare Corporation | NDA | Current |
| 0941-0487 | 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 |
|---|---|---|
| 45138 | SUPPL | 2016-08-16 |
| 45137 | SUPPL | 2016-08-16 |
| 45136 | SUPPL | 2016-08-16 |
| 45135 | SUPPL | 2016-08-16 |
| 45134 | SUPPL | 2016-08-16 |
| 45133 | SUPPL | 2016-08-16 |
| 11005 | SUPPL | 2015-09-04 |
| 610 | SUPPL | 2015-09-04 |
| 13162 | SUPPL | 2015-07-31 |
| 609 | SUPPL | 2015-07-31 |
| 33289 | SUPPL | 2015-07-30 |
| 11004 | SUPPL | 2015-07-30 |
| 33288 | SUPPL | 2015-02-10 |
| 13161 | SUPPL | 2015-02-10 |
| 608 | SUPPL | 2013-04-24 |
| 11003 | SUPPL | 2013-04-23 |
| 11002 | SUPPL | 2009-01-02 |
| 13160 | SUPPL | 2008-12-24 |
| 607 | SUPPL | 2005-08-11 |
| 606 | SUPPL | 2005-08-11 |