Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074726
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 206630 BRECKENRIDGE
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 206347 NOVEL LABS INC
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 209922 PRINSTON INC

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 206630 BRECKENRIDGE
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 15MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 209922 PRINSTON INC

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 206630 BRECKENRIDGE
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 206347 NOVEL LABS INC
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 209922 PRINSTON INC

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