Home Applications 214727 Application 214727
Type ANDA
Sponsor NEXUS PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 POTASSIUM CHLORIDE 10MEQ POTASSIUM CHLORIDE INJECTABLE;INJECTION 14.9MG/ML No No 002 POTASSIUM CHLORIDE 10MEQ POTASSIUM CHLORIDE INJECTABLE;INJECTION 745MG/100ML No No 003 POTASSIUM CHLORIDE 20MEQ POTASSIUM CHLORIDE INJECTABLE;INJECTION 29.8MG/ML No No 004 POTASSIUM CHLORIDE 20MEQ POTASSIUM CHLORIDE INJECTABLE;INJECTION 1.49GM/100ML No No 005 POTASSIUM CHLORIDE 40MEQ POTASSIUM CHLORIDE INJECTABLE;INJECTION 2.98GM/100ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214727-001 POTASSIUM CHLORIDE 10MEQ POTASSIUM CHLORIDE 14.9MG/ML INJECTABLE / INJECTION AP 2021-03-18 A214727-002 POTASSIUM CHLORIDE 10MEQ POTASSIUM CHLORIDE 745MG/100ML INJECTABLE / INJECTION AP 2021-03-18 A214727-003 POTASSIUM CHLORIDE 20MEQ POTASSIUM CHLORIDE 29.8MG/ML INJECTABLE / INJECTION AP 2021-03-18 A214727-004 POTASSIUM CHLORIDE 20MEQ POTASSIUM CHLORIDE 1.49GM/100ML INJECTABLE / INJECTION AP 2021-03-18 A214727-005 POTASSIUM CHLORIDE 40MEQ POTASSIUM CHLORIDE 2.98GM/100ML INJECTABLE / INJECTION AP 2021-03-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 1 of 5 · 170 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 A214727-001 POTASSIUM CHLORIDE 10MEQ 14.9MG/ML INJECTABLE / INJECTION AP 2021-03-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214727-002 POTASSIUM CHLORIDE 10MEQ 745MG/100ML INJECTABLE / INJECTION AP 2021-03-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214727-003 POTASSIUM CHLORIDE 20MEQ 29.8MG/ML INJECTABLE / INJECTION AP 2021-03-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214727-004 POTASSIUM CHLORIDE 20MEQ 1.49GM/100ML INJECTABLE / INJECTION AP 2021-03-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214727-005 POTASSIUM CHLORIDE 40MEQ 2.98GM/100ML INJECTABLE / INJECTION AP 2021-03-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214727-001 POTASSIUM CHLORIDE 10MEQ 14.9MG/ML INJECTABLE / INJECTION AP 2021-03-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214727-002 POTASSIUM CHLORIDE 10MEQ 745MG/100ML INJECTABLE / INJECTION AP 2021-03-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214727-003 POTASSIUM CHLORIDE 20MEQ 29.8MG/ML INJECTABLE / INJECTION AP 2021-03-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214727-004 POTASSIUM CHLORIDE 20MEQ 1.49GM/100ML INJECTABLE / INJECTION AP 2021-03-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214727-005 POTASSIUM CHLORIDE 40MEQ 2.98GM/100ML INJECTABLE / INJECTION AP 2021-03-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214727-001 POTASSIUM CHLORIDE 10MEQ 14.9MG/ML INJECTABLE / INJECTION AP 2021-03-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214727-002 POTASSIUM CHLORIDE 10MEQ 745MG/100ML INJECTABLE / INJECTION AP 2021-03-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214727-003 POTASSIUM CHLORIDE 20MEQ 29.8MG/ML INJECTABLE / INJECTION AP 2021-03-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214727-004 POTASSIUM CHLORIDE 20MEQ 1.49GM/100ML INJECTABLE / INJECTION AP 2021-03-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214727-005 POTASSIUM CHLORIDE 40MEQ 2.98GM/100ML INJECTABLE / INJECTION AP 2021-03-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214727-001 POTASSIUM CHLORIDE 10MEQ 14.9MG/ML INJECTABLE / INJECTION AP 2021-03-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214727-002 POTASSIUM CHLORIDE 10MEQ 745MG/100ML INJECTABLE / INJECTION AP 2021-03-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214727-003 POTASSIUM CHLORIDE 20MEQ 29.8MG/ML INJECTABLE / INJECTION AP 2021-03-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214727-004 POTASSIUM CHLORIDE 20MEQ 1.49GM/100ML INJECTABLE / INJECTION AP 2021-03-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214727-005 POTASSIUM CHLORIDE 40MEQ 2.98GM/100ML INJECTABLE / INJECTION AP 2021-03-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214727-001 POTASSIUM CHLORIDE 10MEQ 14.9MG/ML INJECTABLE / INJECTION AP 2021-03-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214727-002 POTASSIUM CHLORIDE 10MEQ 745MG/100ML INJECTABLE / INJECTION AP 2021-03-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214727-003 POTASSIUM CHLORIDE 20MEQ 29.8MG/ML INJECTABLE / INJECTION AP 2021-03-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214727-004 POTASSIUM CHLORIDE 20MEQ 1.49GM/100ML INJECTABLE / INJECTION AP 2021-03-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214727-005 POTASSIUM CHLORIDE 40MEQ 2.98GM/100ML INJECTABLE / INJECTION AP 2021-03-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214727-001 POTASSIUM CHLORIDE 10MEQ 14.9MG/ML INJECTABLE / INJECTION AP 2021-03-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214727-002 POTASSIUM CHLORIDE 10MEQ 745MG/100ML INJECTABLE / INJECTION AP 2021-03-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214727-003 POTASSIUM CHLORIDE 20MEQ 29.8MG/ML INJECTABLE / INJECTION AP 2021-03-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214727-004 POTASSIUM CHLORIDE 20MEQ 1.49GM/100ML INJECTABLE / INJECTION AP 2021-03-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214727-005 POTASSIUM CHLORIDE 40MEQ 2.98GM/100ML INJECTABLE / INJECTION AP 2021-03-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214727-001 POTASSIUM CHLORIDE 10MEQ 14.9MG/ML INJECTABLE / INJECTION AP 2021-03-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214727-002 POTASSIUM CHLORIDE 10MEQ 745MG/100ML INJECTABLE / INJECTION AP 2021-03-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214727-003 POTASSIUM CHLORIDE 20MEQ 29.8MG/ML INJECTABLE / INJECTION AP 2021-03-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214727-004 POTASSIUM CHLORIDE 20MEQ 1.49GM/100ML INJECTABLE / INJECTION AP 2021-03-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214727-005 POTASSIUM CHLORIDE 40MEQ 2.98GM/100ML INJECTABLE / INJECTION AP 2021-03-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214727-001 POTASSIUM CHLORIDE 10MEQ 14.9MG/ML INJECTABLE / INJECTION AP 2021-03-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214727-002 POTASSIUM CHLORIDE 10MEQ 745MG/100ML INJECTABLE / INJECTION AP 2021-03-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214727-003 POTASSIUM CHLORIDE 20MEQ 29.8MG/ML INJECTABLE / INJECTION AP 2021-03-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214727-004 POTASSIUM CHLORIDE 20MEQ 1.49GM/100ML INJECTABLE / INJECTION AP 2021-03-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214727-005 POTASSIUM CHLORIDE 40MEQ 2.98GM/100ML INJECTABLE / INJECTION AP 2021-03-18 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 170 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 14789-107 Potassium Chloride Potassium Chloride Nexus Pharamaceuticals Inc. ANDA Current 14789-108 Potassium Chloride Potassium Chloride Nexus Pharamaceuticals Inc. ANDA Current 14789-109 Potassium Chloride Potassium Chloride Nexus Pharamaceuticals Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 67046 ORIG 2021-04-13