Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019439
Company: SCHERING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/13/1986 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
06/13/2008 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019439s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019439s022ltr.pdf
02/21/2001 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

09/01/2000 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/21/1997 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/15/1996 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

11/08/1993 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/20/1990 SUPPL-15 Labeling

Label is not available on this site.

08/08/1989 SUPPL-14 Labeling

Label is not available on this site.

03/15/1989 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

08/03/1990 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/1989 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/15/1989 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/26/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/04/1988 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

06/02/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/05/1988 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

08/23/1988 SUPPL-3 Labeling

Label is not available on this site.

08/12/1987 SUPPL-2 Labeling

Label is not available on this site.

08/23/1988 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/13/2008 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019439s022lbl.pdf

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