Application 020163

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	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
002	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
003	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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020163-001	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	1992-12-04
N020163-002	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	1992-12-04
N020163-003	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	1992-12-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N020163-001	AT
N020163-002	AT
N020163-003	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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
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	N020163-001	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	1992-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020163-002	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	1992-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020163-003	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	1992-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020163-001	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	1992-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020163-002	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	1992-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020163-003	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	1992-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020163-001	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	1992-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020163-002	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	1992-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020163-003	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	1992-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020163-001	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	1992-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020163-002	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	1992-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020163-003	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	1992-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020163-001	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	1992-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020163-002	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	1992-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020163-003	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	1992-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020163-001	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	1992-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020163-002	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	1992-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020163-003	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	1992-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020163-001	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	1992-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020163-002	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	1992-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020163-003	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	1992-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020163-001	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	1992-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020163-002	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	1992-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020163-003	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	1992-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020163-001	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	1992-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020163-002	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	1992-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020163-003	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	1992-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020163-001	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	1992-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020163-002	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	1992-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020163-003	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	1992-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020163-001	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	1992-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020163-002	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	1992-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020163-003	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	1992-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020163-001	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	1992-12-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020163-002	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	1992-12-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020163-003	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	1992-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020163-001	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	1992-12-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020163-002	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	1992-12-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020163-003	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	1992-12-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020163-001	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	1992-12-04	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020163-001	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020163-002	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020163-003	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020163-001	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020163-002	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020163-003	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020163-001	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020163-002	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020163-003	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020163-001	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020163-002	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020163-003	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020163-001	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020163-002	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020163-003	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020163-001	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020163-002	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020163-003	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020163-001	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020163-002	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020163-003	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020163-001	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020163-002	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020163-003	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020163-001	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020163-002	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020163-003	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020163-001	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020163-002	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020163-003	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020163-001	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020163-002	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020163-003	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020163-001	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020163-002	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020163-003	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020163-001	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020163-002	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020163-003	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020163-001	AT	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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier application applno (NDA): 020163 application number: NDA020163 ndc (product): 0941-0429 ndc (product): 0941-0426 ndc (product): 0941-0427

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0941-0426	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0426	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0426	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corpora	NDA	Current
0941-0426	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0426	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0426	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0426	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0426	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0426	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0426	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0427	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0427	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0427	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corpora	NDA	Current
0941-0427	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0427	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0427	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0427	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0427	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0427	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0427	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0429	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0429	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0429	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corpora	NDA	Current
0941-0429	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0429	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0429	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0429	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0429	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0429	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current
0941-0429	DIANEAL PD-2 with Dextrose	sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74451	SUPPL	2023-06-06
74443	SUPPL	2023-06-06
45073	SUPPL	2016-08-17
45139	SUPPL	2016-08-16
34327	SUPPL	2015-09-04
2113	SUPPL	2015-09-04
12284	SUPPL	2015-02-10
2112	SUPPL	2015-02-10
21235	SUPPL	2013-04-24
34326	SUPPL	2013-04-23
21234	SUPPL	2005-08-11
2111	SUPPL	2005-08-11