Application 017378

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINERMAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATEINJECTABLE;INJECTION30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLYesYes
002PLASMA-LYTE A IN PLASTIC CONTAINERMAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATEINJECTABLE;INJECTION30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017378-001PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINERMAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982
N017378-002PLASMA-LYTE A IN PLASTIC CONTAINERMAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-11-22

Therapeutic equivalence codes#

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

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

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 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-03-09 01:35 UTC2022-03N017378-001PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N017378-002PLASMA-LYTE A IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONRLD, RS1982-11-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017378-001PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12N017378-002PLASMA-LYTE A IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONRLD, RS1982-11-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017378-001PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONRLD, RS, Approved before 198287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017378-002PLASMA-LYTE A IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONRLD, RS1982-11-2287673890dc5c…
2021-03-12 10:30 UTC2021-03N017378-001PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONRLD, RS, Approved before 19825aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N017378-002PLASMA-LYTE A IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONRLD, RS1982-11-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017378-001PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONRLD, RS, Approved before 19828869cabd3fbd…
2020-12-22 03:56 UTC2020-12N017378-002PLASMA-LYTE A IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONRLD, RS1982-11-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017378-001PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982c0c555d07b60…
2020-11-12 02:37 UTC2020-11N017378-002PLASMA-LYTE A IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONRLD, RS1982-11-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017378-001PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONRLD, RS, Approved before 19823f01610625f2…
2019-12-14 00:12 UTC2019-12N017378-002PLASMA-LYTE A IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONRLD, RS1982-11-223f01610625f2…
2019-09-15 20:21 UTC2019-09N017378-001PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982b00525d2431f…
2019-09-15 20:21 UTC2019-09N017378-002PLASMA-LYTE A IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONRLD, RS1982-11-22b00525d2431f…
2019-07-19 19:46 UTC2019-07N017378-001PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982ea99ee380514…
2019-07-19 19:46 UTC2019-07N017378-002PLASMA-LYTE A IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONRLD, RS1982-11-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017378-001PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017378-002PLASMA-LYTE A IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-11-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017378-001PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19821c564ffb4f44…
2024-02-18 07:12 UTC2024-02N017378-002PLASMA-LYTE A IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-11-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017378-001PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N017378-002PLASMA-LYTE A IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-11-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017378-001PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017378-002PLASMA-LYTE A IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-11-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017378-001PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19829b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017378-002PLASMA-LYTE A IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-11-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017378-001PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017378-002PLASMA-LYTE A IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-11-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017378-001PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017378-002PLASMA-LYTE A IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-11-223f0d92c62455…
2023-05-13 08:27 UTC2023-05N017378-001PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982053a50430f4f…
2023-05-13 08:27 UTC2023-05N017378-002PLASMA-LYTE A IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-11-22053a50430f4f…
2023-01-26 05:58 UTC2023-01N017378-001PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONRLD, RS, Approved before 19823bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N017378-002PLASMA-LYTE A IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONRLD, RS1982-11-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017378-001PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017378-002PLASMA-LYTE A IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-11-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017378-001PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N017378-002PLASMA-LYTE A IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONAPRLD, RS1982-11-22f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 53 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N017378-002AP184e616aacf4f…
2026-08-18 06:07:402026-07N017378-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017378-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017378-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017378-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017378-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017378-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017378-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017378-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017378-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017378-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017378-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017378-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017378-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017378-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017378-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017378-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017378-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N017378-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017378-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017378-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017378-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017378-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017378-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017378-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017378-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N017378-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017378-002AP15c6f7cd8ea54…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017378-001AP16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017378-002AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017378-001AP11c564ffb4f44…
2024-02-18 07:12 UTC2024-02N017378-002AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017378-001AP1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N017378-002AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017378-001AP1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017378-002AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017378-001AP19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017378-002AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017378-001AP1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017378-002AP1a67488948f0b…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Plasma-Lyte ASODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDEBaxter Healthcare Corporation6ec9e61c-2c26-402f-8604-f446b2e340582019-08-05Warnings, Adverse reactionsExact 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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-0179Plasma-Lyte 148SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0179Plasma-Lyte 148SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0179Plasma-Lyte 148SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0179Plasma-Lyte 148SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0179Plasma-Lyte 148SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0221Plasma-Lyte ASodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride and Magnesium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0221Plasma-Lyte ASodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride and Magnesium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0221Plasma-Lyte ASodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride and Magnesium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0221Plasma-Lyte ASodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride and Magnesium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0221Plasma-Lyte ASodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride and Magnesium ChlorideBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59606SUPPL2019-08-07
59588SUPPL2019-08-06
33252SUPPL2013-09-17
13122SUPPL2013-09-13
10979SUPPL2009-02-04
13121SUPPL2009-01-30
13120SUPPL2002-04-03