Home Applications 017634 Application 017634
Type NDA
Sponsor BAXTER HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML Yes No 002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML Yes No 003 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;224MG/100ML Yes No 004 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;75MG/100ML Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N017634-001 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE 5GM/100ML;150MG/100ML INJECTABLE / INJECTION AP RLD, Approved before 1982 N017634-002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE 5GM/100ML;300MG/100ML INJECTABLE / INJECTION AP RLD, Approved before 1982 N017634-003 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE 5GM/100ML;224MG/100ML INJECTABLE / INJECTION RLD, Approved before 1982 N017634-004 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE 5GM/100ML;75MG/100ML INJECTABLE / INJECTION AP RLD, Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 5 of 5 · 176 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 N017634-001 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER 5GM/100ML;150MG/100ML INJECTABLE / INJECTION AP RLD, Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N017634-002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 5GM/100ML;300MG/100ML INJECTABLE / INJECTION AP RLD, Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N017634-003 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER 5GM/100ML;224MG/100ML INJECTABLE / INJECTION RLD, Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N017634-004 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER 5GM/100ML;75MG/100ML INJECTABLE / INJECTION AP RLD, Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N017634-001 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER 5GM/100ML;150MG/100ML INJECTABLE / INJECTION AP RLD, Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N017634-002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 5GM/100ML;300MG/100ML INJECTABLE / INJECTION AP RLD, Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N017634-003 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER 5GM/100ML;224MG/100ML INJECTABLE / INJECTION RLD, Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N017634-004 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER 5GM/100ML;75MG/100ML INJECTABLE / INJECTION AP RLD, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N017634-001 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER 5GM/100ML;150MG/100ML INJECTABLE / INJECTION AP RLD, Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N017634-002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 5GM/100ML;300MG/100ML INJECTABLE / INJECTION AP RLD, Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N017634-003 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER 5GM/100ML;224MG/100ML INJECTABLE / INJECTION RLD, Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N017634-004 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER 5GM/100ML;75MG/100ML INJECTABLE / INJECTION AP RLD, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N017634-001 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER 5GM/100ML;150MG/100ML INJECTABLE / INJECTION AP RLD, Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N017634-002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER 5GM/100ML;300MG/100ML INJECTABLE / INJECTION AP RLD, Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N017634-003 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER 5GM/100ML;224MG/100ML INJECTABLE / INJECTION RLD, Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N017634-004 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER 5GM/100ML;75MG/100ML INJECTABLE / INJECTION AP RLD, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 135 observed states.
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.
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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0338-0683 Potassium Chloride in Dextrose Potassium Chloride and Dextrose Monohydrate Baxter Healthcare Corporation NDA Current 0338-0683 Potassium Chloride in Dextrose Potassium Chloride and Dextrose Monohydrate Baxter Healthcare Corporation NDA Current 0338-0683 Potassium Chloride in Dextrose Potassium Chloride and Dextrose Monohydrate Baxter Healthcare Corporation NDA Current 0338-0683 Potassium Chloride in Dextrose Potassium Chloride and Dextrose Monohydrate Baxter Healthcare Corporation NDA Current 0338-0683 Potassium Chloride in Dextrose Potassium Chloride and Dextrose Monohydrate Baxter Healthcare Corporation NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 59349 SUPPL 2019-07-16 59339 SUPPL 2019-07-16 48608 SUPPL 2017-05-31 48607 SUPPL 2017-05-31 48595 SUPPL 2017-05-31 48594 SUPPL 2017-05-31 33323 SUPPL 2015-01-09 13873 SUPPL 2014-12-24 33322 SUPPL 2005-08-31 669 SUPPL 2005-08-31 33321 SUPPL 2005-05-25 668 SUPPL 2005-05-25 13872 SUPPL 2004-06-02