Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019123
Company: UPSHER SMITH LABS
Company: UPSHER SMITH LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KLOR-CON | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB2 | Yes | No |
| KLOR-CON | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB2 | 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 |
|---|---|---|---|---|---|---|---|
| 04/17/1986 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/NDA/pre96/019123_s000.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/30/2018 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019123s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019123Orig1s036ltr.pdf | |
| 11/29/2013 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/02/2007 | SUPPL-27 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019123s027lbl.pdf | |
| 04/13/2006 | SUPPL-24 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019123s024ltr.pdf |
| 05/24/2004 | SUPPL-22 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19123slr022ltr.pdf |
| 11/21/2003 | SUPPL-21 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19123slr021ltr.pdf |
| 07/18/1996 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/18/1995 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/08/1994 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/16/1994 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/02/1993 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/31/1991 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/17/1990 | SUPPL-13 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/21/1989 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/18/1990 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/18/1989 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/24/1989 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/26/1992 | SUPPL-8 | Efficacy-Accelerated Approval Confirmatory Study |
Label is not available on this site. |
||
| 11/07/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1988 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 07/31/1987 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/25/1987 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/26/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/17/1987 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/30/2018 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019123s036lbl.pdf | |
| 01/02/2007 | SUPPL-27 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019123s027lbl.pdf | |
| 01/02/2007 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019123s027lbl.pdf |
KLOR-CON
TABLET, EXTENDED RELEASE;ORAL; 8MEQ
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| KLOR-CON | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 019123 | UPSHER SMITH LABS |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210921 | AUROBINDO PHARMA |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 211797 | GRANULES |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 204662 | MYLAN |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 206759 | NOVEL LABS INC |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 205993 | PADAGIS US |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 217412 | RISING |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210733 | STRIDES PHARMA |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 209314 | YICHANG HUMANWELL |
TABLET, EXTENDED RELEASE;ORAL; 10MEQ
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| KLOR-CON | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 019123 | UPSHER SMITH LABS |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210921 | AUROBINDO PHARMA |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 211797 | GRANULES |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 204662 | MYLAN |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 206759 | NOVEL LABS INC |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 205993 | PADAGIS US |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 217412 | RISING |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210733 | STRIDES PHARMA |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 209314 | YICHANG HUMANWELL |