Home Applications 206814 Application 206814
Type NDA
Sponsor GENUS LIFESCIENCES Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 POTASSIUM CHLORIDE POTASSIUM CHLORIDE SOLUTION;ORAL 20MEQ/15ML Yes No 002 POTASSIUM CHLORIDE POTASSIUM CHLORIDE SOLUTION;ORAL 40MEQ/15ML Yes Yes 003 POKONZA POTASSIUM CHLORIDE SOLUTION;ORAL 10MEQ/15ML Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N206814-001 POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA RLD 2014-12-22 N206814-002 POTASSIUM CHLORIDE POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA RLD, RS 2014-12-22 N206814-003 POKONZA POTASSIUM CHLORIDE 10MEQ/15ML SOLUTION / ORAL RLD 2025-11-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206814-001 12539314 2039-03-07 Drug product 2026-02-04 N206814-002 12539314 2039-03-07 Drug product 2026-02-04
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 3 · 91 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 2026-09-14 22:38:34 2026-08 N206814-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA RLD 2014-12-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206814-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA RLD, RS 2014-12-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206814-003 POKONZA 10MEQ/15ML SOLUTION / ORAL RLD 2025-11-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N206814-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA RLD 2014-12-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206814-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA RLD, RS 2014-12-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206814-003 POKONZA 10MEQ/15ML SOLUTION / ORAL RLD 2025-11-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206814-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA RLD 2014-12-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206814-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA RLD, RS 2014-12-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206814-003 POKONZA 10MEQ/15ML SOLUTION / ORAL RLD 2025-11-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206814-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA RLD 2014-12-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206814-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA RLD, RS 2014-12-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206814-003 POKONZA 10MEQ/15ML SOLUTION / ORAL RLD 2025-11-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206814-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA RLD 2014-12-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206814-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA RLD, RS 2014-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206814-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA RLD 2014-12-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206814-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA RLD, RS 2014-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206814-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA RLD 2014-12-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206814-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA RLD, RS 2014-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206814-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA RLD 2014-12-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206814-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA RLD, RS 2014-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206814-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA RLD 2014-12-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206814-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA RLD, RS 2014-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206814-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA RLD 2014-12-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206814-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA RLD, RS 2014-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206814-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA RLD 2014-12-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206814-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA RLD, RS 2014-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206814-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA RLD 2014-12-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206814-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA RLD, RS 2014-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206814-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA RLD 2014-12-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206814-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA RLD, RS 2014-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206814-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA RLD 2014-12-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206814-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA RLD, RS 2014-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206814-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA RLD 2014-12-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206814-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA RLD, RS 2014-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206814-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA RLD 2014-12-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N206814-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA RLD, RS 2014-12-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206814-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA RLD 2014-12-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206814-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA RLD, RS 2014-12-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206814-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA RLD 2014-12-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N206814-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA RLD, RS 2014-12-22 5d02ea3f76ae…
Observed Orange Book normalized TE history# Normalized TE history page 3 of 3 · 86 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N206814-001 12539314 2039-03-07 Drug product 2026-02-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206814-002 12539314 2039-03-07 Drug product 2026-02-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 N206814-001 12539314 2039-03-07 Drug product 2026-02-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206814-002 12539314 2039-03-07 Drug product 2026-02-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206814-001 12539314 2039-03-07 Drug product 2026-02-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206814-002 12539314 2039-03-07 Drug product 2026-02-04 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N206814-001 12539314 2039-03-07 Drug product 2026-02-04 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N206814-002 12539314 2039-03-07 Drug product 2026-02-04 a50c72e98297…
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 · 2 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 · 31 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0603-1542 Potassium Chloride Potassium Chloride Par Pharmaceutical NDA Current 0603-1542 Potassium Chloride Potassium Chloride Par Pharmaceutical NDA Current 0603-1542 Potassium Chloride Potassium Chloride Par Pharmaceutical NDA Current 0603-1543 Potassium Chloride Potassium Chloride Par Pharmaceutical NDA Current 0603-1543 Potassium Chloride Potassium Chloride Par Pharmaceutical NDA Current 0603-1543 Potassium Chloride Potassium Chloride Par Pharmaceutical NDA Current 17856-1542 Potassium Chloride Potassium Chloride Atlantic Biologicals Corps NDA Current 17856-1542 Potassium Chloride Potassium Chloride Atlantic Biologicals Corps NDA Current 17856-1543 Potassium Chloride Potassium Chloride ATLANTIC BIOLOGICALS CORP. NDA Current 17856-1543 Potassium Chloride Potassium Chloride ATLANTIC BIOLOGICALS CORP. NDA Current 17856-1544 Potassium Chloride Potassium Chloride ATLANTIC BIOLOGICALS CORP. NDA Current 17856-1544 Potassium Chloride Potassium Chloride ATLANTIC BIOLOGICALS CORP. NDA Current 64950-320 Potassium Chloride Potassium Chloride Genus Lifesciences Inc. NDA Current 64950-320 Potassium Chloride Potassium Chloride Genus Lifesciences Inc. NDA Current 64950-320 Potassium Chloride Potassium Chloride Genus Lifesciences Inc. NDA Current 66689-047 Potassium Chloride Potassium Chloride VistaPharm, Inc. NDA Current 66689-047 Potassium Chloride Potassium Chloride VistaPharm, Inc. NDA Current 66689-047 Potassium Chloride Potassium Chloride VistaPharm, Inc. NDA Current 66689-047 Potassium Chloride Potassium Chloride VistaPharm, Inc. NDA Current 66689-047 Potassium Chloride Potassium Chloride VistaPharm, Inc. NDA Current 66689-047 Potassium Chloride Potassium Chloride VistaPharm, Inc. NDA Current 66689-047 Potassium Chloride Potassium Chloride VistaPharm, Inc. NDA Current 66689-047 Potassium Chloride Potassium Chloride VistaPharm, Inc. NDA Current 66689-048 Potassium Chloride Potassium Chloride VistaPharm, Inc. NDA Current 66689-048 Potassium Chloride Potassium Chloride VistaPharm, Inc. NDA Current 66689-048 Potassium Chloride Potassium Chloride VistaPharm, Inc. NDA Current 66689-048 Potassium Chloride Potassium Chloride VistaPharm, Inc. NDA Current 66689-048 Potassium Chloride Potassium Chloride VistaPharm, Inc. NDA Current 66689-048 Potassium Chloride Potassium Chloride VistaPharm, Inc. NDA Current 66689-048 Potassium Chloride Potassium Chloride VistaPharm, Inc. NDA Current 66689-048 Potassium Chloride Potassium Chloride VistaPharm, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 62078 SUPPL 2020-03-09 62054 SUPPL 2020-03-06 58836 SUPPL 2019-05-23 58833 SUPPL 2019-05-22 57614 SUPPL 2019-02-15 57587 SUPPL 2019-02-13 44949 ORIG 2015-03-10 43528 ORIG 2015-03-10 32829 ORIG 2014-12-30 19736 ORIG 2014-12-23