Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 206814
Company: GENUS LIFESCIENCES
Company: GENUS LIFESCIENCES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION;ORAL | Prescription | AA | Yes | No |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION;ORAL | Prescription | AA | Yes | 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 |
---|---|---|---|---|---|---|---|
12/22/2014 | ORIG-1 | Approval | Type 7 - Drug Already Marketed without Approved NDA | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206814lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206814Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206814Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206814Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/05/2020 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206814s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206814Orig1s009ltr.pdf | |
05/01/2019 | SUPPL-8 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206814s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206814Orig1s008ltr.pdf | |
02/04/2019 | SUPPL-7 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206814s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206814Orig1s007ltr_.pdf | |
07/14/2015 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/05/2020 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206814s009lbl.pdf | |
05/01/2019 | SUPPL-8 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206814s008lbl.pdf |
02/04/2019 | SUPPL-7 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206814s007lbl.pdf | |
02/04/2019 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206814s007lbl.pdf | |
12/22/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206814lbl.pdf |
POTASSIUM CHLORIDE
SOLUTION;ORAL; 20MEQ/15ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 210041 | AMNEAL |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 214892 | ANDA REPOSITORY |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 211067 | APOTEX |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 216156 | BELCHER |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION;ORAL | Prescription | Yes | AA | 206814 | GENUS LIFESCIENCES |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 213392 | GRANULES |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 209786 | NOVEL LABS INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 210766 | PHARM ASSOC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 214656 | RUBICON |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 211648 | SCIEGEN PHARMS INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 211665 | STRIDES PHARMA |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 213062 | WES PHARMA INC |
SOLUTION;ORAL; 40MEQ/15ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 210041 | AMNEAL |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 214892 | ANDA REPOSITORY |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 211067 | APOTEX |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 216156 | BELCHER |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION;ORAL | Prescription | Yes | AA | 206814 | GENUS LIFESCIENCES |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 213392 | GRANULES |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 209786 | NOVEL LABS INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 210766 | PHARM ASSOC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 214656 | RUBICON |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 211648 | SCIEGEN PHARMS INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 213062 | WES PHARMA INC |