Application 211067
- Type
- ANDA
- Sponsor
- APOTEX
Application Products#
| 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 |
Orange Book products#
| 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.
| 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#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A211067-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211067-002 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211067-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211067-002 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A211067-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211067-002 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211067-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211067-002 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211067-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211067-002 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211067-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211067-002 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211067-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211067-002 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211067-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211067-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211067-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211067-002 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A211067-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A211067-002 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211067-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211067-002 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211067-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211067-002 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211067-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211067-002 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A211067-001 | AA | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A211067-002 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211067-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211067-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A211067-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A211067-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A211067-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A211067-002 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A211067-001 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A211067-002 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A211067-001 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A211067-002 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A211067-001 | AA | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A211067-002 | AA | 1 | 782e0a99824c… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A211067-001 | CGT | 2019-02-25 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A211067-002 | CGT | 2019-03-06 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A211067-001 | CGT | 2019-02-25 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A211067-002 | CGT | 2019-03-06 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A211067-001 | CGT | 2019-02-25 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A211067-002 | CGT | 2019-03-06 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A211067-001 | CGT | 2019-02-25 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A211067-002 | CGT | 2019-03-06 | ea99ee380514… |
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| 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 |
|---|---|---|
| 55182 | ORIG | 2018-08-16 |