Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018279
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
K-TAB POTASSIUM CHLORIDE 10MEQ TABLET, EXTENDED RELEASE;ORAL Prescription AB3 Yes No
K-TAB POTASSIUM CHLORIDE 8MEQ TABLET, EXTENDED RELEASE;ORAL Prescription BC Yes No
K-TAB POTASSIUM CHLORIDE 20MEQ 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
06/09/1980 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/30/2018 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018279Orig1s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018279Orig1s037ltr.pdf
06/26/2014 SUPPL-34 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018279s034lbl.pdf
11/25/2013 SUPPL-33 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018279s033lbl.pdf
06/03/2014 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

08/01/2013 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

09/30/2014 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

02/15/2012 SUPPL-29 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018279s029ltr.pdf
12/14/2004 SUPPL-27 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18279s027ltr.pdf
12/24/2002 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

10/02/2002 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1998 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/29/1997 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

11/21/1996 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

01/27/1993 SUPPL-20 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/26/1990 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/02/1989 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/01/1988 SUPPL-16 Labeling

Label is not available on this site.

08/01/1988 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/1987 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

06/17/1986 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/1986 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/14/1986 SUPPL-10 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/25/1985 SUPPL-9 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/13/1984 SUPPL-8 Labeling

Label is not available on this site.

08/01/1984 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

07/02/1982 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/10/1982 SUPPL-5 Labeling

Label is not available on this site.

04/29/1981 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/16/1981 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/03/1981 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/04/1981 SUPPL-1 Manufacturing (CMC)-Packaging

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-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018279Orig1s037lbl.pdf
06/26/2014 SUPPL-34 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018279s034lbl.pdf
11/25/2013 SUPPL-33 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018279s033lbl.pdf

K-TAB

TABLET, EXTENDED RELEASE;ORAL; 10MEQ
TE Code = AB3

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
K-TAB POTASSIUM CHLORIDE 10MEQ TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB3 018279 ABBVIE
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 209688 VITRUVIAS THERAP

TABLET, EXTENDED RELEASE;ORAL; 20MEQ
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
K-TAB POTASSIUM CHLORIDE 20MEQ TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB2 018279 ABBVIE
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 210098 PII
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 209688 VITRUVIAS THERAP

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