Application 218960
- Type
- ANDA
- Sponsor
- TARO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | SOLUTION;ORAL | 20MEQ/15ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218960-001 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION / ORAL | AA | 2025-07-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A218960-001 | AA |
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 | A218960-001 | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION / ORAL | AA | 2025-07-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A218960-001 | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION / ORAL | AA | 2025-07-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218960-001 | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION / ORAL | AA | 2025-07-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218960-001 | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION / ORAL | AA | 2025-07-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218960-001 | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION / ORAL | AA | 2025-07-22 | 6a471c1ec25d… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218960-001 | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION / ORAL | AA | 2025-07-22 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A218960-001 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A218960-001 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A218960-001 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218960-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A218960-001 | AA | 1 | 6a471c1ec25d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218960-001 | AA | 1 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Potassium Chloride | POTASSIUM CHLORIDE | Genus Lifesciences | 14cd12ee-a4a3-465a-9550-58c9ef0e4f21 | 2025-07-21 | Warnings, Adverse reactions | Potassium Chloride POTASSIUM CHLORIDE |
| Potassium chloride | POTASSIUM CHLORIDE | Camber Pharmaceuticals, Inc. | fb2f6e74-4c1f-40c5-88a1-b88c069d4c75 | 2025-07-17 | Warnings, Adverse reactions | Potassium chloride POTASSIUM CHLORIDE |
| potassium chloride | POTASSIUM CHLORIDE | Solco Healthcare LLC | 52d91d76-8c7f-40f1-9f5c-e05962cabedd | 2025-07-15 | Warnings, Adverse reactions | potassium chloride POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Upsher-Smith Laboratories, LLC | 616f0de7-8843-44a1-8fa6-274d889286aa | 2025-07-14 | Warnings, Adverse reactions | Potassium Chloride POTASSIUM CHLORIDE |
| KLOR-CON | POTASSIUM CHLORIDE | Upsher-Smith Laboratories, LLC | 1ff53330-065c-4213-9c0c-ac498621d09d | 2025-07-14 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| KLOR-CON | POTASSIUM CHLORIDE | Upsher-Smith Laboratories, LLC | e61a4522-b91d-400a-952c-6f035e4610dd | 2025-07-14 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| KLOR-CON M | POTASSIUM CHLORIDE | Upsher-Smith Laboratories, LLC | b89910f6-4ff5-4a62-8269-696f7c10e4f6 | 2025-07-14 | Warnings, Adverse reactions | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Upsher-SmithLaboratories, LLC | ad584ce4-a64d-4851-80e9-0eeedc0b9d06 | 2025-07-10 | Warnings, Adverse reactions | Potassium Chloride POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | American Health Packaging | b165ad93-1dc1-4863-9f0b-d7b97c42c94c | 2025-06-23 | Warnings, Adverse reactions | Potassium Chloride POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Upsher-Smith Laboratories, LLC | a230185f-5493-487d-892a-5219869b4e47 | 2025-05-05 | Warnings, Adverse reactions | Potassium Chloride POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Bryant Ranch Prepack | ab147ac2-d7d5-46d1-a2de-d866219197c1 | 2025-04-28 | Warnings, Adverse reactions | Potassium Chloride POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Endo USA, Inc. | a64d7151-09a6-474c-83fc-36c7cf582d32 | 2025-03-26 | Warnings, Adverse reactions | Potassium Chloride POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | bf632e1d-73f3-4df1-ad12-e555fa6a56e9 | 2025-02-27 | Warnings, Adverse reactions | Potassium Chloride POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Endo USA, Inc. | e5214432-3517-4a90-9412-036752bd1139 | 2025-02-10 | Warnings, Adverse reactions | Potassium Chloride POTASSIUM CHLORIDE |
| Kali Muriaticum Kit Refill | POTASSIUM CHLORIDE | Washington Homeopathic Products | 099223af-a3f6-c370-e063-6394a90aa17f | 2025-01-28 | Warnings | POTASSIUM CHLORIDE |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Direct_Rx | 946b9568-671d-172a-e053-2a95a90ac827 | 2025-01-22 | Warnings, Adverse reactions | POTASSIUM CHLORIDE POTASSIUM CHLORIDE |
| D-125 | POTASSIUM CHLORIDE | DNA Labs, Inc. | 71b92f48-edee-49a4-a87f-7b284e1b45a0 | 2025-01-13 | Warnings | POTASSIUM CHLORIDE |
| Potassium Chloride | POTASSIUM CHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 81a53ecd-2612-4efe-9491-415fff3f86e5 | 2025-01-09 | Warnings, Adverse reactions | Potassium Chloride POTASSIUM CHLORIDE |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 9508355e-e1ed-412b-e053-2a95a90aac8e | 2025-01-08 | Warnings, Adverse reactions | POTASSIUM CHLORIDE POTASSIUM CHLORIDE |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 951ffdc3-d54f-d5e1-e053-2a95a90a79e6 | 2025-01-08 | Warnings, Adverse reactions | POTASSIUM CHLORIDE POTASSIUM CHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.