Application 205993
- Type
- ANDA
- Sponsor
- PADDOCK LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 8MEQ | No | No |
| 002 | POTASSIUM CHLORIDE | 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 |
|---|---|---|---|---|---|---|---|
| A205993-001 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | |
| A205993-002 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A205993-001 | AB2 |
| A205993-002 | AB2 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A205993-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205993-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205993-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205993-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205993-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205993-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205993-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205993-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205993-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205993-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205993-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205993-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205993-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205993-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205993-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205993-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205993-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205993-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205993-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205993-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205993-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205993-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205993-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205993-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205993-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205993-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A205993-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A205993-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205993-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205993-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A205993-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A205993-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A205993-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A205993-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A205993-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A205993-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A205993-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A205993-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A205993-001 | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A205993-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2015-11-05 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A205993-001 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205993-002 | AB2 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205993-001 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205993-002 | AB2 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A205993-001 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205993-002 | AB2 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205993-001 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205993-002 | AB2 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205993-001 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205993-002 | AB2 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205993-001 | AB2 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205993-002 | AB2 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205993-001 | AB2 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205993-002 | AB2 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205993-001 | AB2 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205993-002 | AB2 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205993-001 | AB2 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205993-002 | AB2 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A205993-001 | AB2 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A205993-002 | AB2 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205993-001 | AB2 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205993-002 | AB2 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205993-001 | AB2 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205993-002 | AB2 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205993-001 | AB2 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205993-002 | AB2 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A205993-001 | AB2 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A205993-002 | AB2 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205993-001 | AB2 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205993-002 | AB2 | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A205993-001 | AB2 | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A205993-002 | AB2 | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A205993-001 | AB2 | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A205993-002 | AB2 | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A205993-001 | AB2 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A205993-002 | AB2 | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A205993-001 | AB2 | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A205993-002 | AB2 | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A205993-001 | AB2 | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A205993-002 | AB2 | 1 | 782e0a99824c… |
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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0574-0274 | Potassium chloride extended release | Potassium chloride | Paddock Laboratories, LLC | ANDA | Current |
| 0574-0274 | Potassium chloride extended release | Potassium chloride | Padagis US LLC | ANDA | Current |
| 0574-0274 | Potassium chloride extended release | Potassium chloride | Padagis US LLC | ANDA | Current |
| 0574-0275 | Potassium chloride extended release | Potassium chloride | Paddock Laboratories, LLC | ANDA | Current |
| 0574-0275 | Potassium chloride extended release | Potassium chloride | Padagis US LLC | ANDA | Current |
| 0574-0275 | Potassium chloride extended release | Potassium chloride | Padagis US LLC | ANDA | Current |
| 55154-6709 | Potassium chloride extended release | Potassium chloride | Cardinal Health | ANDA | Current |
| 55154-6709 | Potassium chloride extended release | Potassium chloride | Cardinal Health | ANDA | Current |
| 55154-6709 | Potassium chloride extended release | Potassium chloride | Cardinal Health 107, LLC | ANDA | Current |
| 55154-6709 | Potassium chloride extended release | Potassium chloride | Cardinal Health | ANDA | Current |
| 63629-8442 | Potassium chloride extended release | Potassium chloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8442 | Potassium chloride extended release | Potassium chloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8442 | Potassium chloride extended release | Potassium chloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8443 | Potassium chloride extended release | Potassium chloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8443 | Potassium chloride extended release | Potassium chloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8443 | Potassium chloride extended release | Potassium chloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8700 | Potassium chloride extended release | Potassium chloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8700 | Potassium chloride extended release | Potassium chloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8700 | Potassium chloride extended release | Potassium chloride | Bryant Ranch Prepack | ANDA | Current |
| 70518-2291 | Potassium chloride extended release | Potassium chloride | REMEDYREPACK INC. | ANDA | Current |
| 71205-996 | Potassium chloride extended release | Potassium chloride | Proficient Rx LP | ANDA | Current |
| 71205-996 | Potassium chloride extended release | Potassium chloride | Proficient Rx LP | ANDA | Current |