Home Applications 211067 Application 211067
Type ANDA
Sponsor APOTEX 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 43 .
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 A211067-001 POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL 2018-08-08 A211067-002 POTASSIUM CHLORIDE POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL 2018-08-08
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 · 86 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 A211067-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL 2018-08-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211067-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL 2018-08-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211067-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL 2018-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211067-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL 2018-08-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211067-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211067-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211067-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211067-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211067-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211067-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211067-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211067-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211067-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211067-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211067-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211067-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211067-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211067-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211067-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211067-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211067-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211067-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211067-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211067-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211067-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211067-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211067-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211067-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211067-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211067-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211067-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211067-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211067-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211067-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211067-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211067-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211067-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211067-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211067-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2018-08-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A211067-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2018-08-08 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
Observed Orange Book exclusivity history# 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 9 of 10 · 200 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Kali muriaticum POTASSIUM CHLORIDE Boiron 8608a8de-8133-1d4b-e053-2991aa0a907a 2023-11-13 Name fallback generic name: POTASSIUM CHLORIDE Kali muriaticum POTASSIUM CHLORIDE Boiron 860887e7-7eaf-78c2-e053-2991aa0a9a75 2023-11-13 Name fallback generic name: POTASSIUM CHLORIDE Kali muriaticum POTASSIUM CHLORIDE Boiron 86086aab-c411-7cf2-e053-2991aa0a81bd 2023-11-13 Name fallback generic name: POTASSIUM CHLORIDE Kali muriaticum POTASSIUM CHLORIDE Boiron 8608a379-c3b7-3053-e053-2a91aa0a2e65 2023-11-13 Name fallback generic name: POTASSIUM CHLORIDE Kali muriaticum POTASSIUM CHLORIDE Boiron 8608f3dd-31bf-0182-e053-2991aa0a1030 2023-11-13 Name fallback generic name: POTASSIUM CHLORIDE Potassium Chloride POTASSIUM CHLORIDE Lupin Pharmaceuticals, Inc. 1f33bcfe-c28a-4800-9241-685d974a5d91 2023-11-08 Warnings, Adverse reactions Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE Kali muriaticum POTASSIUM CHLORIDE Boiron caaad470-7be1-11e6-b409-424c58303031 2023-10-16 Name fallback generic name: POTASSIUM CHLORIDE Potassium Chloride POTASSIUM CHLORIDE A-S Medication Solutions e1670127-c551-441b-bac4-39f10a6d156f 2023-09-18 Warnings, Adverse reactions Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE Potassium Chloride POTASSIUM CHLORIDE A-S Medication Solutions f1af7e05-68ba-438e-a63b-cd8c23960c85 2023-09-06 Warnings, Adverse reactions Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE Potassium Chloride Extended-Release POTASSIUM CHLORIDE A-S Medication Solutions 0dc6c066-1a59-4798-b9e6-d66872245389 2023-09-04 Warnings, Adverse reactions Name fallback generic name: POTASSIUM CHLORIDE Kali muriaticum POTASSIUM CHLORIDE Boiron 86099779-8dbd-a9eb-e053-2991aa0ab7a7 2023-07-20 Name fallback generic name: POTASSIUM CHLORIDE Potassium chloride POTASSIUM CHLORIDE ANI Pharmaceuticals, Inc. 0128a879-7185-4b70-b0bb-d108ff1c9542 2023-07-20 Warnings, Adverse reactions Name fallback brand name: Potassium chloride generic name: POTASSIUM CHLORIDE Potassium Chloride POTASSIUM CHLORIDE Nexus Pharamaceuticals Inc. 765ef38c-df36-46d1-9062-61e30ff46a86 2023-06-13 Warnings, Adverse reactions Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE Potassium Chloride POTASSIUM CHLORIDE Fresenius Kabi USA, LLC fcd4f458-ce27-417e-9bb6-de1cc49d44b9 2023-02-27 Warnings, Adverse reactions Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE Potassium Chloride POTASSIUM CHLORIDE A-S Medication Solutions 87cc7349-5a07-4a39-be97-4e1013814f30 2023-02-06 Warnings, Adverse reactions Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE POTASSIUM CHLORIDE EXTENDED RELEASE POTASSIUM CHLORIDE Granules Pharmaceuticals Inc. 9f8d2886-9ecd-4cbf-a84a-2d221cb3497c 2023-01-27 Warnings, Adverse reactions Name fallback generic name: POTASSIUM CHLORIDE Kali muriaticum POTASSIUM CHLORIDE Boiron 8608d5a3-93e6-e8e2-e053-2a91aa0aaedc 2023-01-23 Name fallback generic name: POTASSIUM CHLORIDE KALI MURIATICUM POTASSIUM CHLORIDE Hyland's Inc. 2e8a4762-d28d-4b64-892f-913e04d18d2d 2022-12-19 Warnings Name fallback generic name: POTASSIUM CHLORIDE Potassium Chloride POTASSIUM CHLORIDE Zydus Pharmaceuticals (USA) Inc. 31e02249-7984-4b8f-9e37-2b79b708ac08 2022-10-18 Warnings, Adverse reactions Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE Potassium Chloride POTASSIUM CHLORIDE Zydus Lifesciences Limited 099c3a36-f460-4191-80e5-0c4153a5c713 2022-10-18 Warnings, Adverse reactions Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
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 · 20 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0904-7061 Potassium Chloride Potassium Chloride Major Pharmaceuticals ANDA Current 0904-7061 Potassium Chloride Potassium Chloride Major Pharmaceuticals ANDA Current 0904-7062 Potassium Chloride Potassium Chloride Major Pharmaceuticals ANDA Current 0904-7062 Potassium Chloride Potassium Chloride Major Pharmaceuticals ANDA Current 0904-7062 Potassium Chloride Potassium Chloride Major Pharmaceuticals ANDA Current 0904-7062 Potassium Chloride Potassium Chloride Major Pharmaceuticals ANDA Current 48433-217 POTASSIUM CHLORIDE POTASSIUM CHLORIDE Safecor Health, LLC ANDA Current 48433-217 POTASSIUM CHLORIDE POTASSIUM CHLORIDE Safecor Health, LLC ANDA Current 48433-218 POTASSIUM CHLORIDE POTASSIUM CHLORIDE Safecor Health, LLC ANDA Current 48433-218 POTASSIUM CHLORIDE POTASSIUM CHLORIDE Safecor Health, LLC ANDA Current 60505-6184 Potassium Chloride Potassium Chloride Apotex Corp ANDA Current 60505-6184 Potassium Chloride Potassium Chloride Apotex Corp ANDA Current 60505-6184 Potassium Chloride Potassium Chloride Apotex Corp ANDA Current 60505-6184 Potassium Chloride Potassium Chloride Apotex Corp ANDA Current 60505-6184 Potassium Chloride Potassium Chloride Apotex Corp ANDA Current 60505-6185 Potassium Chloride Potassium Chloride Apotex Corp ANDA Current 60505-6185 Potassium Chloride Potassium Chloride Apotex Corp ANDA Current 60505-6185 Potassium Chloride Potassium Chloride Apotex Corp ANDA Current 60505-6185 Potassium Chloride Potassium Chloride Apotex Corp ANDA Current 60505-6185 Potassium Chloride Potassium Chloride Apotex Corp ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 55182 ORIG 2018-08-16