Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019123
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 LTD
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 207528 SIGMAPHARM LABS LLC
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 LTD
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 207528 SIGMAPHARM LABS LLC
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

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