Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074726
Company: UPSHER SMITH LABS
Company: UPSHER SMITH LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KLOR-CON M10 | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB1 | No | No |
| KLOR-CON M15 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB1 | No | No |
| KLOR-CON M20 | POTASSIUM CHLORIDE | 20MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB1 | 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 |
|---|---|---|---|---|---|---|---|
| 11/20/1998 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74726_KLOR-CON_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74726ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074726_klor-con_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/03/2011 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 11/24/2008 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 12/19/2002 | SUPPL-18 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 06/06/2003 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 06/06/2003 | SUPPL-16 | Manufacturing (CMC)-New Strength |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/074726Orig1s016.pdf |
| 03/29/2002 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/29/2002 | SUPPL-13 | Manufacturing (CMC)-Manufacturing Process |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/074726Orig1s013.pdf |
| 02/08/2002 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/06/2003 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 06/28/2001 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/28/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/28/2001 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/28/2001 | SUPPL-5 | Manufacturing (CMC)-Manufacturing Process |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/074726Orig1s005.pdf |
| 01/05/2001 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/10/2000 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/09/2000 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 08/09/2000 | SUPPL-1 | Manufacturing (CMC)-New Strength |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/074726Orig1s001.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/20/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74726_KLOR-CON_Prntlbl.pdf |
KLOR-CON M10
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 | 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 |
KLOR-CON M15
TABLET, EXTENDED RELEASE;ORAL; 15MEQ
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| KLOR-CON M15 | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 074726 | UPSHER SMITH LABS |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 214422 | ASCENT PHARMS INC |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 209922 | PRINSTON INC |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 15MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 216321 | RUBICON |
KLOR-CON M20
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 | 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 |