Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203562
Company: GLENMARK PHARMS LTD
Company: GLENMARK PHARMS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB1 | No | No |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB1 | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/26/2016 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/26/2021 | SUPPL-3 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
02/26/2021 | SUPPL-2 | Labeling-Patient Package Insert |
Label is not available on this site. |
POTASSIUM CHLORIDE
TABLET, EXTENDED RELEASE;ORAL; 10MEQ
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
KLOR-CON M10 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 074726 | UPSHER SMITH LABS |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 075604 | ACTAVIS LABS FL INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 076368 | ADARE PHARMS INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 212861 | AMNEAL |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 214422 | ASCENT PHARMS INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 203562 | GLENMARK PHARMS LTD |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 214452 | GRANULES |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 214395 | GUANGZHOU NOVAKEN |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 216269 | MACLEODS PHARMS LTD |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 206347 | NOVEL LABS INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 209922 | PRINSTON INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 216321 | RUBICON |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 210395 | ZYDUS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 20MEQ
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
KLOR-CON M20 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 074726 | UPSHER SMITH LABS |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 075604 | ACTAVIS LABS FL INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 076368 | ADARE PHARMS INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 212861 | AMNEAL |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 214422 | ASCENT PHARMS INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 203562 | GLENMARK PHARMS LTD |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 214452 | GRANULES |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 214395 | GUANGZHOU NOVAKEN |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 216269 | MACLEODS PHARMS LTD |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 206347 | NOVEL LABS INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 209922 | PRINSTON INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 216321 | RUBICON |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 210395 | ZYDUS PHARMS |