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 8 of 10 · 189 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join POTASSIUM CHLORIDE POTASSIUM CHLORIDE Sun Pharmaceutical Industries, Inc. 4d90d03d-7f0e-4d49-9e80-628dbc7165c0 2024-01-10 Warnings, Adverse reactions Name fallback brand name: POTASSIUM CHLORIDE generic name: POTASSIUM CHLORIDE Potassium Chloride Extended-Release POTASSIUM CHLORIDE Sun Pharmaceutical Industries, Inc. 8ed8ea55-8b15-f718-e053-2a95a90a587a 2024-01-10 Warnings, Adverse reactions Name fallback generic name: POTASSIUM CHLORIDE Potassium Chloride Extended-Release POTASSIUM CHLORIDE Proficient Rx LP d0ce0bdf-5f24-4093-813f-881c61d7fcc7 2024-01-01 Warnings, Adverse reactions Name fallback generic name: POTASSIUM CHLORIDE POTASSIUM CHLORIDE EXTENDED RELEASE POTASSIUM CHLORIDE Adare Pharmaceuticals Inc 22edb0e6-4e45-4e91-aead-3581cca293a0 2023-12-20 Warnings, Adverse reactions Name fallback generic name: POTASSIUM CHLORIDE Potassium Chloride POTASSIUM CHLORIDE A-S Medication Solutions 5aa0adf8-7b84-4cb0-be31-5c3333a6cc44 2023-12-11 Warnings, Adverse reactions Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE Potassium Chloride POTASSIUM CHLORIDE A-S Medication Solutions 5c4b0be5-625e-435f-9d2c-9d8fb407a8ea 2023-12-05 Warnings, Adverse reactions Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE Potassium Chloride POTASSIUM CHLORIDE A-S Medication Solutions d033c3b3-3ed6-4f23-a555-bae40cf0c48f 2023-12-05 Warnings, Adverse reactions Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE Potassium Chloride POTASSIUM CHLORIDE Sun Pharmaceutical Industries, Inc. 0a1f2f64-3b0b-5e5c-e063-6294a90a7185 2023-11-14 Warnings, Adverse reactions Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE Kali muriaticum POTASSIUM CHLORIDE Boiron 86093c75-6de0-bb16-e053-2991aa0ab6ef 2023-11-13 Name fallback generic name: POTASSIUM CHLORIDE Kali muriaticum POTASSIUM CHLORIDE Boiron 86090ebb-0fb2-2c9c-e053-2a91aa0a0561 2023-11-13 Name fallback generic name: POTASSIUM CHLORIDE 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
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