Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215725
Company: RUBICON
Company: RUBICON
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB3 | No | No |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB3 | No | No |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/25/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/22/2024 | SUPPL-5 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
02/15/2023 | SUPPL-2 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
POTASSIUM CHLORIDE
TABLET, EXTENDED RELEASE;ORAL; 10MEQ
TE Code = AB3
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 215725 | RUBICON |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 209688 | TWI PHARMS |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 212561 | YICHANG HUMANWELL |
TABLET, EXTENDED RELEASE;ORAL; 20MEQ
TE Code = AB3
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 215725 | RUBICON |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 209688 | TWI PHARMS |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 212561 | YICHANG HUMANWELL |