Home Applications 209786 Application 209786
Type ANDA
Sponsor NOVEL LABS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 POTASSIUM CHLORIDE POTASSIUM CHLORIDE SOLUTION;ORAL 20MEQ/15ML No No 002 POTASSIUM CHLORIDE POTASSIUM CHLORIDE SOLUTION;ORAL 40MEQ/15ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A209786-001 POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-29 A209786-002 POTASSIUM CHLORIDE POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 82 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 A209786-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209786-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209786-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209786-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209786-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209786-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209786-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209786-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209786-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209786-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209786-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209786-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209786-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209786-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209786-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209786-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209786-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209786-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209786-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209786-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209786-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209786-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209786-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209786-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209786-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209786-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209786-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209786-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209786-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209786-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209786-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A209786-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209786-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A209786-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209786-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A209786-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209786-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A209786-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209786-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-29 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A209786-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-29 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 40032-168 potassium chloride potassium chloride Novel Laboratories, Inc. ANDA Current 40032-168 potassium chloride potassium chloride Novel Laboratories, Inc. ANDA Current 40032-169 potassium chloride potassium chloride Novel Laboratories, Inc. ANDA Current 40032-169 potassium chloride potassium chloride Novel Laboratories, Inc. ANDA Current 43386-168 POTASSIUM CHLORIDE POTASSIUM CHLORIDE Lupin Pharmaceuticals,Inc. ANDA Current 43386-168 POTASSIUM CHLORIDE POTASSIUM CHLORIDE Lupin Pharmaceuticals,Inc. ANDA Current 43386-168 POTASSIUM CHLORIDE POTASSIUM CHLORIDE Lupin Pharmaceuticals,Inc. ANDA Current 43386-169 POTASSIUM CHLORIDE POTASSIUM CHLORIDE Lupin Pharmaceuticals,Inc. ANDA Current 43386-169 POTASSIUM CHLORIDE POTASSIUM CHLORIDE Lupin Pharmaceuticals,Inc. ANDA Current 43386-169 POTASSIUM CHLORIDE POTASSIUM CHLORIDE Lupin Pharmaceuticals,Inc. ANDA Current