Home Applications 213392 Application 213392
Type ANDA
Sponsor GRANULES PHARMS 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 44 .
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 A213392-001 POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2021-01-29 A213392-002 POTASSIUM CHLORIDE POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2021-01-29
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 2 · 76 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 2026-10-15 13:18:30 2026-09 A213392-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2021-01-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 A213392-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2021-01-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 A213392-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2021-01-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213392-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2021-01-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213392-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2021-01-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213392-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2021-01-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213392-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2021-01-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213392-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2021-01-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213392-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2021-01-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213392-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2021-01-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213392-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2021-01-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213392-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2021-01-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213392-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2021-01-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213392-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2021-01-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213392-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2021-01-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213392-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2021-01-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213392-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2021-01-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213392-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2021-01-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213392-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2021-01-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213392-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2021-01-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213392-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2021-01-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213392-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2021-01-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213392-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2021-01-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213392-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2021-01-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213392-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2021-01-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213392-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2021-01-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213392-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2021-01-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213392-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2021-01-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213392-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2021-01-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213392-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2021-01-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213392-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2021-01-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213392-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2021-01-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213392-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2021-01-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213392-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2021-01-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213392-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2021-01-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213392-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2021-01-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213392-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2021-01-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A213392-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2021-01-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213392-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2021-01-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A213392-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2021-01-29 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 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 9 of 10 · 189 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Potassium Chloride POTASSIUM CHLORIDE BluePoint Laboratories 73c911bb-4d39-4793-acba-90ed4b0eff46 2022-10-17 Warnings, Adverse reactions Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE POTASSIUM CHLORIDE POTASSIUM CHLORIDE Dr. Reddys Laboratories, Inc. dda82a38-0c08-4947-99b7-915c2949bf16 2022-08-29 Warnings, Adverse reactions Name fallback brand name: POTASSIUM CHLORIDE generic name: POTASSIUM CHLORIDE Potassium Chloride POTASSIUM CHLORIDE Actavis Pharma, Inc. db002ae3-f54c-40a4-9cb4-e5681bf426e3 2022-08-01 Warnings, Adverse reactions Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE Potassium Chloride POTASSIUM CHLORIDE Actavis Pharma, Inc. ed5baaf6-270b-4dd3-b100-36030c0098fc 2022-08-01 Warnings, Adverse reactions Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE KALIUM MURIATICUM 6X POTASSIUM CHLORIDE Seroyal USA 22c95b6a-dd5d-476e-e054-00144ff8d46c 2022-07-07 Warnings Name fallback generic name: POTASSIUM CHLORIDE POTASSIUM CHLORIDE POTASSIUM CHLORIDE B. Braun Medical Inc. ab67b151-8368-4321-b562-bad5eff7b740 2022-02-21 Warnings, Adverse reactions Name fallback brand name: POTASSIUM CHLORIDE generic name: POTASSIUM CHLORIDE Potassium Chloride POTASSIUM CHLORIDE Tris Pharma Inc 159ddd0b-847e-4ecc-b3b2-9634cbb4dfa9 2022-01-26 Warnings, Adverse reactions Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE Potassium Chloride POTASSIUM CHLORIDE Guardian Drug Company 3d460e84-27a0-485c-8b11-58d03d9064aa 2021-07-28 Warnings, Adverse reactions Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE Potassium Chloride POTASSIUM CHLORIDE Aurobindo Pharma Limited deb6b462-397f-4527-ae26-40dc5d5857bc 2021-04-30 Warnings, Adverse reactions Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE Potassium Chloride POTASSIUM CHLORIDE Aurobindo Pharma Limited d43beabe-b801-4319-ad36-9a80856b94bd 2021-04-29 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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 70010-072 POTASSIUM CHLORIDE POTASSIUM CHLORIDE Granules Pharmaceuticals Inc. ANDA Current 70010-072 POTASSIUM CHLORIDE POTASSIUM CHLORIDE Granules Pharmaceuticals Inc. ANDA Current 70010-073 POTASSIUM CHLORIDE POTASSIUM CHLORIDE Granules Pharmaceuticals Inc. ANDA Current 70010-073 POTASSIUM CHLORIDE POTASSIUM CHLORIDE Granules Pharmaceuticals Inc. ANDA Current