Application 076368
- Type
- ANDA
- Sponsor
- ADARE PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 20MEQ | 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 |
|---|---|---|---|---|---|---|---|
| A076368-001 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | |
| A076368-002 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076368-001 | AB1 |
| A076368-002 | AB1 |
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 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A076368-001 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2004-08-18 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A076368-002 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | AB1 | 2019-06-05 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076368-001 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076368-002 | AB1 | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A076368-001 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076368-002 | AB1 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076368-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076368-002 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076368-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076368-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076368-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076368-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076368-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076368-002 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076368-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076368-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076368-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076368-002 | AB1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076368-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076368-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076368-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076368-002 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076368-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076368-002 | AB1 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076368-001 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076368-002 | AB1 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076368-001 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076368-002 | AB1 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076368-001 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076368-002 | AB1 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076368-001 | AB1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076368-002 | AB1 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076368-001 | AB1 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A076368-002 | AB1 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076368-001 | AB1 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076368-002 | AB1 | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A076368-001 | AB1 | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A076368-002 | AB1 | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A076368-001 | AB1 | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A076368-002 | AB1 | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A076368-001 | AB1 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076368-002 | AB1 | 1 | 74a2ff9319b5… |
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 Extended-Release | POTASSIUM CHLORIDE | REMEDYREPACK INC. | 7ec22e8e-6643-44fe-804d-ca0b0b266663 | 2026-07-31 | Warnings, Adverse reactions | 076368 ANDA076368 |
| Potassium Chloride Extended-Release | POTASSIUM CHLORIDE | Bryant Ranch Prepack | ff44dcd5-b255-4d80-83ee-3c8f922c99eb | 2026-03-11 | Warnings, Adverse reactions | 076368 ANDA076368 |
| Potassium Chloride | POTASSIUM CHLORIDE | Major Pharmaceuticals | 5c2e888c-2f1e-4d5a-a456-20774ca83302 | 2026-02-04 | Warnings, Adverse reactions | 076368 ANDA076368 |
| Potassium Chloride Extended-Release | POTASSIUM CHLORIDE | Major Pharmaceuticals | 7d74652b-3513-4ebb-8b47-10b3603d04a7 | 2026-02-04 | Warnings, Adverse reactions | 076368 ANDA076368 |
| Potassium Chloride Extended-Release | POTASSIUM CHLORIDE | Bryant Ranch Prepack | 2feda15e-f325-41fe-a442-41a8cc62b855 | 2025-11-06 | Warnings, Adverse reactions | 076368 ANDA076368 |
| Potassium Chloride Extended-Release | POTASSIUM CHLORIDE | Bryant Ranch Prepack | 6fc9eef0-3dfc-4344-85c7-9f11d9b99b65 | 2025-11-06 | Warnings, Adverse reactions | 076368 ANDA076368 |
| Potassium Chloride Extended-Release | POTASSIUM CHLORIDE | Bryant Ranch Prepack | 1b64b0c9-31a2-4ee7-8818-66de906ebeda | 2025-11-06 | Warnings, Adverse reactions | 076368 ANDA076368 |
| Potassium Chloride | POTASSIUM CHLORIDE | PD-Rx Pharmaceuticals, Inc. | 47a87fb6-5e61-41c9-b759-10f7c74a67ce | 2025-08-05 | Warnings, Adverse reactions | 076368 ANDA076368 |
| Potassium Chloride Extended-Release | POTASSIUM CHLORIDE | Bryant Ranch Prepack | 55747ef3-9437-4bdc-9ebd-a74d8e2de1cf | 2024-10-29 | Warnings, Adverse reactions | 076368 ANDA076368 |
| Potassium Chloride Extended-Release | POTASSIUM CHLORIDE | Bryant Ranch Prepack | 473369cb-3a9b-437c-b08e-8fb38034c507 | 2024-10-03 | Warnings, Adverse reactions | 076368 ANDA076368 |
| Potassium Chloride Extended-Release | POTASSIUM CHLORIDE | Bryant Ranch Prepack | 863e6980-4a66-48a5-a14f-828a00480c93 | 2024-08-23 | Warnings, Adverse reactions | 076368 ANDA076368 |
| Potassium Chloride Extended-Release | POTASSIUM CHLORIDE | American Health Packaging | 8c12c5f8-5950-44e3-9473-a0b95187b43c | 2024-08-22 | Warnings, Adverse reactions | 076368 ANDA076368 |
| Potassium Chloride Extended-Release | POTASSIUM CHLORIDE | Bryant Ranch Prepack | 7427c29e-55c1-4c30-b091-058c8bec592f | 2024-08-12 | Warnings, Adverse reactions | 076368 ANDA076368 |
| Potassium Chloride Extended-Release | POTASSIUM CHLORIDE | Bryant Ranch Prepack | 80dd5de2-5066-472b-b1f8-88070a5c7388 | 2024-08-05 | Warnings, Adverse reactions | 076368 ANDA076368 |
| Potassium Chloride Extended-Release | POTASSIUM CHLORIDE | Bryant Ranch Prepack | b5a6b6f2-d073-4bd3-a66c-bf34ccabfe51 | 2024-07-18 | Warnings, Adverse reactions | 076368 ANDA076368 71335-1900 |
| Potassium Chloride Extended-Release | POTASSIUM CHLORIDE | Sun Pharmaceutical Industries, Inc. | 8ed8ea55-8b15-f718-e053-2a95a90a587a | 2024-01-10 | Warnings, Adverse reactions | 076368 ANDA076368 |
| Potassium Chloride | POTASSIUM CHLORIDE | Sun Pharmaceutical Industries, Inc. | 0a1f2f64-3b0b-5e5c-e063-6294a90a7185 | 2023-11-14 | Warnings, Adverse reactions | 076368 ANDA076368 |
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 |
|---|---|---|---|---|---|
| 71335-1900 | Potassium Chloride Extended-Release | Potassium Chloride | Bryant Ranch Prepack | ANDA | Current |