Application 017850
- Type
- NDA
- Sponsor
- APOTHECON
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KLOTRIX | POTASSIUM CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 10MEQ | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N017850-001 | KLOTRIX | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 |
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.
| 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 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N017850-001 | KLOTRIX | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | f41ea6bd6efb… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Kali muriaticum | POTASSIUM CHLORIDE | Boiron | 8608a379-c3b7-3053-e053-2a91aa0a2e65 | 2023-11-13 | POTASSIUM CHLORIDE | |
| Kali muriaticum | POTASSIUM CHLORIDE | Boiron | 8608f3dd-31bf-0182-e053-2991aa0a1030 | 2023-11-13 | POTASSIUM CHLORIDE | |
| Potassium Chloride | POTASSIUM CHLORIDE | Lupin Pharmaceuticals, Inc. | 1f33bcfe-c28a-4800-9241-685d974a5d91 | 2023-11-08 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Kali muriaticum | POTASSIUM CHLORIDE | Boiron | caaad470-7be1-11e6-b409-424c58303031 | 2023-10-16 | POTASSIUM CHLORIDE | |
| Potassium Chloride | POTASSIUM CHLORIDE | A-S Medication Solutions | e1670127-c551-441b-bac4-39f10a6d156f | 2023-09-18 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | A-S Medication Solutions | f1af7e05-68ba-438e-a63b-cd8c23960c85 | 2023-09-06 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride Extended-Release | POTASSIUM CHLORIDE | A-S Medication Solutions | 0dc6c066-1a59-4798-b9e6-d66872245389 | 2023-09-04 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Kali muriaticum | POTASSIUM CHLORIDE | Boiron | 86099779-8dbd-a9eb-e053-2991aa0ab7a7 | 2023-07-20 | POTASSIUM CHLORIDE | |
| Potassium chloride | POTASSIUM CHLORIDE | ANI Pharmaceuticals, Inc. | 0128a879-7185-4b70-b0bb-d108ff1c9542 | 2023-07-20 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Nexus Pharamaceuticals Inc. | 765ef38c-df36-46d1-9062-61e30ff46a86 | 2023-06-13 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Fresenius Kabi USA, LLC | fcd4f458-ce27-417e-9bb6-de1cc49d44b9 | 2023-02-27 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | A-S Medication Solutions | 87cc7349-5a07-4a39-be97-4e1013814f30 | 2023-02-06 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| POTASSIUM CHLORIDE EXTENDED RELEASE | POTASSIUM CHLORIDE | Granules Pharmaceuticals Inc. | 9f8d2886-9ecd-4cbf-a84a-2d221cb3497c | 2023-01-27 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Kali muriaticum | POTASSIUM CHLORIDE | Boiron | 8608d5a3-93e6-e8e2-e053-2a91aa0aaedc | 2023-01-23 | POTASSIUM CHLORIDE | |
| KALI MURIATICUM | POTASSIUM CHLORIDE | Hyland's Inc. | 2e8a4762-d28d-4b64-892f-913e04d18d2d | 2022-12-19 | Warnings | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Zydus Pharmaceuticals (USA) Inc. | 31e02249-7984-4b8f-9e37-2b79b708ac08 | 2022-10-18 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Zydus Lifesciences Limited | 099c3a36-f460-4191-80e5-0c4153a5c713 | 2022-10-18 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | BluePoint Laboratories | 73c911bb-4d39-4793-acba-90ed4b0eff46 | 2022-10-17 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Dr. Reddys Laboratories, Inc. | dda82a38-0c08-4947-99b7-915c2949bf16 | 2022-08-29 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Actavis Pharma, Inc. | db002ae3-f54c-40a4-9cb4-e5681bf426e3 | 2022-08-01 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.