Application 214728
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 10MEQ | No | No |
| 002 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 15MEQ | No | No |
| 003 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 20MEQ | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A214728-001 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | ||
| A214728-002 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | ||
| A214728-003 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A214728-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A214728-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A214728-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A214728-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A214728-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A214728-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A214728-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A214728-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A214728-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A214728-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A214728-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A214728-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A214728-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A214728-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A214728-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A214728-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A214728-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A214728-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A214728-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A214728-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A214728-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A214728-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A214728-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A214728-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A214728-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A214728-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A214728-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A214728-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214728-001 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214728-002 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214728-003 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE / ORAL | 2021-03-31 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A214728-001 | AB1 | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A214728-002 | AB1 | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A214728-003 | AB1 | 1 | 87673890dc5c… |
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 | Aurobindo Pharma Limited | deb6b462-397f-4527-ae26-40dc5d5857bc | 2021-04-30 | Warnings, Adverse reactions | 214728 ANDA214728 59651-431 59651-430 59651-429 |
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 |
|---|---|---|---|---|---|
| 59651-429 | Potassium Chloride | Potassium Chloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-429 | Potassium Chloride | Potassium Chloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-430 | Potassium Chloride | Potassium Chloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-430 | Potassium Chloride | Potassium Chloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-431 | Potassium Chloride | Potassium Chloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-431 | Potassium Chloride | Potassium Chloride | Aurobindo Pharma Limited | ANDA | Current |