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FDA ANDA · ANDA070618

POTASSIUM CHLORIDE

Sponsor: COPLEY PHARM

APPLICATION
ANDA070618
TYPE
ANDA
ORIGINAL APPROVAL
1987-09-09
LATEST ACTION
2006-01-23
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

POTASSIUM CHLORIDEDiscontinued
POTASSIUM CHLORIDE 8MEQ · TABLET, EXTENDED RELEASE · ORAL

Approval history

2006-01-23Labeling · Supplement 22AP
2005-04-14Labeling · Supplement 21AP
2002-07-18Manufacturing (CMC) · Supplement 14AP
2002-07-18Manufacturing (CMC) · Supplement 17AP
2002-07-18Manufacturing (CMC) · Supplement 15AP
2002-07-18Manufacturing (CMC) · Supplement 13AP
2002-04-10Manufacturing (CMC) · Supplement 16AP
2002-01-23Manufacturing (CMC) · Supplement 9AP
2001-10-31Manufacturing (CMC) · Supplement 12AP
2001-10-31Manufacturing (CMC) · Supplement 10AP
2001-10-31Manufacturing (CMC) · Supplement 11AP
2001-04-02Manufacturing (CMC) · Supplement 8AP
1999-06-17Manufacturing (CMC) · Supplement 7AP
1999-03-23Manufacturing (CMC) · Supplement 6AP
1998-06-11Manufacturing (CMC) · Supplement 5AP
1996-12-12Manufacturing (CMC) · Supplement 4AP
1996-05-31Manufacturing (CMC) · Supplement 3AP
1992-02-27Manufacturing (CMC) · Supplement 2AP
1989-03-17Labeling · Supplement 1AP
1987-09-09OriginalAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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