Application 018883
- Type
- NDA
- Sponsor
- FRESENIUS MEDCL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DELFLEX 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 | DELFLEX 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 |
| 003 | DELFLEX 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 |
| 004 | DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM 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 | No | No |
| 005 | DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM 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 | No | No |
| 006 | DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM 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 | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018883-001 | DELFLEX 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 | RLD, RS | 1984-11-30 | |
| N018883-002 | DELFLEX 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 | RLD, RS | 1984-11-30 | |
| N018883-003 | DELFLEX 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 | RLD, RS | 1984-11-30 | |
| N018883-004 | DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM 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, RS | 1984-11-30 |
| N018883-005 | DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM 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, RS | 1984-11-30 |
| N018883-006 | DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM 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, RS | 1984-11-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N018883-004 | AT |
| N018883-005 | AT |
| N018883-006 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N018883-001 | DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | RLD, RS | 1984-11-30 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N018883-002 | DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | RLD, RS | 1984-11-30 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N018883-003 | DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | RLD, RS | 1984-11-30 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N018883-004 | DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, RS | 1984-11-30 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N018883-005 | DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, RS | 1984-11-30 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N018883-006 | DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, RS | 1984-11-30 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N018883-001 | DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | RLD, RS | 1984-11-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N018883-002 | DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | RLD, RS | 1984-11-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N018883-003 | DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | RLD, RS | 1984-11-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N018883-004 | DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, RS | 1984-11-30 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N018883-005 | DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, RS | 1984-11-30 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N018883-006 | DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, RS | 1984-11-30 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N018883-001 | DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | RLD, RS | 1984-11-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N018883-002 | DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | RLD, RS | 1984-11-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N018883-003 | DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | RLD, RS | 1984-11-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N018883-004 | DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, RS | 1984-11-30 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018883-005 | DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, RS | 1984-11-30 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018883-006 | DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, RS | 1984-11-30 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N018883-001 | DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | RLD, RS | 1984-11-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018883-002 | DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | RLD, RS | 1984-11-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018883-003 | DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | RLD, RS | 1984-11-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018883-004 | DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, RS | 1984-11-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018883-005 | DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, RS | 1984-11-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018883-006 | DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, RS | 1984-11-30 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018883-001 | DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | RLD, RS | 1984-11-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018883-002 | DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | RLD, RS | 1984-11-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018883-003 | DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | RLD, RS | 1984-11-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018883-004 | DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, RS | 1984-11-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018883-005 | DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, RS | 1984-11-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018883-006 | DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, RS | 1984-11-30 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N018883-001 | DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | RLD, RS | 1984-11-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018883-002 | DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | RLD, RS | 1984-11-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018883-003 | DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | RLD, RS | 1984-11-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018883-004 | DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, RS | 1984-11-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018883-005 | DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, RS | 1984-11-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018883-006 | DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, RS | 1984-11-30 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018883-001 | DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | RLD, RS | 1984-11-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018883-002 | DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | RLD, RS | 1984-11-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018883-003 | DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML | SOLUTION / INTRAPERITONEAL | RLD, RS | 1984-11-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018883-004 | DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER | 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION / INTRAPERITONEAL | AT | RLD, RS | 1984-11-30 | fd3edfee7708… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N018883-004 | AT | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N018883-005 | AT | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N018883-006 | AT | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N018883-004 | AT | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N018883-005 | AT | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N018883-006 | AT | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N018883-004 | AT | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018883-005 | AT | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018883-006 | AT | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N018883-004 | AT | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018883-005 | AT | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018883-006 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018883-004 | AT | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018883-005 | AT | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018883-006 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N018883-004 | AT | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018883-005 | AT | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018883-006 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018883-004 | AT | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018883-005 | AT | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018883-006 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018883-001 | AT | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018883-002 | AT | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018883-003 | AT | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018883-004 | AT | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018883-005 | AT | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018883-006 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018883-001 | AT | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018883-002 | AT | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018883-003 | AT | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018883-004 | AT | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018883-005 | AT | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018883-006 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018883-001 | AT | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018883-002 | AT | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018883-003 | AT | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018883-004 | AT | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018883-005 | AT | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018883-006 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018883-001 | AT | 1 | 5bbf6a4d5a75… |
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 |
|---|---|---|---|---|---|
| 49230-188 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate | Fresenius Medical Care North America | NDA | Current |
| 49230-188 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | Fresenius Medical Care North America | NDA | Current |
| 49230-188 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | Fresenius Medical Care North America | NDA | Current |
| 49230-188 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | Fresenius Medical Care North America | NDA | Current |
| 49230-188 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | Fresenius Medical Care North America | NDA | Current |
| 49230-188 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | Fresenius Medical Care North America | NDA | Current |
| 49230-188 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | Fresenius Medical Care North America | NDA | Current |
| 49230-188 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | Fresenius Medical Care North America | NDA | Current |
| 49230-188 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | Fresenius Medical Care North America | NDA | Current |
| 49230-188 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | Fresenius Medical Care North America | NDA | Current |
| 49230-188 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | Fresenius Medical Care North America | NDA | Current |
| 49230-188 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate | Fresenius Medical Care North America | NDA | Current |
| 49230-191 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate | Fresenius Medical Care North America | NDA | Current |
| 49230-191 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | Fresenius Medical Care North America | NDA | Current |
| 49230-191 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | Fresenius Medical Care North America | NDA | Current |
| 49230-191 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | Fresenius Medical Care North America | NDA | Current |
| 49230-191 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | Fresenius Medical Care North America | NDA | Current |
| 49230-191 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | Fresenius Medical Care North America | NDA | Current |
| 49230-191 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | Fresenius Medical Care North America | NDA | Current |
| 49230-191 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | Fresenius Medical Care North America | NDA | Current |
| 49230-191 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | Fresenius Medical Care North America | NDA | Current |
| 49230-191 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | Fresenius Medical Care North America | NDA | Current |
| 49230-191 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | Fresenius Medical Care North America | NDA | Current |
| 49230-191 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate | Fresenius Medical Care North America | NDA | Current |
| 49230-194 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate | Fresenius Medical Care North America | NDA | Current |
| 49230-194 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate | Fresenius Medical Care North America | NDA | Current |
| 49230-197 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate | Fresenius Medical Care North America | NDA | Current |
| 49230-197 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate | Fresenius Medical Care North America | NDA | Current |
| 49230-200 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate | Fresenius Medical Care North America | NDA | Current |
| 49230-200 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate | Fresenius Medical Care North America | NDA | Current |
| 49230-203 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate | Fresenius Medical Care North America | NDA | Current |
| 49230-203 | DELFLEX | Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate | Fresenius Medical Care North America | NDA | Current |