Application 017378

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER	MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE	INJECTABLE;INJECTION	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	Yes	Yes
002	PLASMA-LYTE A IN PLASTIC CONTAINER	MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE	INJECTABLE;INJECTION	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017378-001	PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER	MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982
N017378-002	PLASMA-LYTE A IN PLASTIC CONTAINER	MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-11-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017378-002	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 3 of 3 · 88 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
2022-10-28 04:53 UTC	2022-10	N017378-001	PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N017378-002	PLASMA-LYTE A IN PLASTIC CONTAINER	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-11-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017378-001	PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N017378-002	PLASMA-LYTE A IN PLASTIC CONTAINER	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-11-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017378-001	PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017378-002	PLASMA-LYTE A IN PLASTIC CONTAINER	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-11-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017378-001	PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017378-002	PLASMA-LYTE A IN PLASTIC CONTAINER	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-11-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N017378-002	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N017378-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017378-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017378-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017378-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017378-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017378-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017378-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017378-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017378-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017378-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017378-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017378-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017378-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017378-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017378-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017378-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017378-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017378-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017378-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017378-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017378-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017378-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017378-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017378-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017378-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017378-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017378-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017378-002	AP	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017378-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017378-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017378-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N017378-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017378-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N017378-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017378-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017378-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017378-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017378-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017378-001	AP	1	`a67488948f0b…`

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
Plasma-Lyte A	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE	Baxter Healthcare Corporation	6ec9e61c-2c26-402f-8604-f446b2e34058	2019-08-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017378 application number: NDA017378 ndc (product): 0338-0221

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0179	Plasma-Lyte 148	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-0179	Plasma-Lyte 148	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-0179	Plasma-Lyte 148	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-0179	Plasma-Lyte 148	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-0179	Plasma-Lyte 148	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-0221	Plasma-Lyte A	Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride and Magnesium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0221	Plasma-Lyte A	Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride and Magnesium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0221	Plasma-Lyte A	Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride and Magnesium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0221	Plasma-Lyte A	Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride and Magnesium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0221	Plasma-Lyte A	Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride and Magnesium Chloride	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59606	SUPPL	2019-08-07
59588	SUPPL	2019-08-06
33252	SUPPL	2013-09-17
13122	SUPPL	2013-09-13
10979	SUPPL	2009-02-04
13121	SUPPL	2009-01-30
13120	SUPPL	2002-04-03