← FDA DRUG APPROVALS

FDA ANDA · ANDA074726

POTASSIUM CHLORIDE

Sponsor: UPSHER SMITH LABS

APPLICATION
ANDA074726
TYPE
ANDA
ORIGINAL APPROVAL
1998-11-20
LATEST ACTION
2011-03-03
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

KLOR-CON M10Prescription
POTASSIUM CHLORIDE 10MEQ · TABLET, EXTENDED RELEASE · ORAL
KLOR-CON M15Prescription
POTASSIUM CHLORIDE 15MEQ · TABLET, EXTENDED RELEASE · ORAL
KLOR-CON M20Prescription
POTASSIUM CHLORIDE 20MEQ · TABLET, EXTENDED RELEASE · ORAL

Approval history

2011-03-03Labeling · Supplement 34AP
2008-11-24Labeling · Supplement 32AP
2003-06-06Labeling · Supplement 17AP
2003-06-06Labeling · Supplement 11AP
2003-06-06Manufacturing (CMC) · Supplement 16 — Review ↗AP
2002-12-19Manufacturing (CMC) · Supplement 18AP
2002-03-29Manufacturing (CMC) · Supplement 13 — Review ↗AP
2002-03-29Manufacturing (CMC) · Supplement 14AP
2002-02-08Manufacturing (CMC) · Supplement 12AP
2001-06-28Labeling · Supplement 8AP
2001-06-28Manufacturing (CMC) · Supplement 6AP
2001-06-28Manufacturing (CMC) · Supplement 7AP
2001-06-28Manufacturing (CMC) · Supplement 5 — Review ↗AP
2001-01-05Manufacturing (CMC) · Supplement 4AP
2000-10-10Manufacturing (CMC) · Supplement 3AP
2000-08-09Labeling · Supplement 2AP
2000-08-09Manufacturing (CMC) · Supplement 1 — Review ↗AP
1998-11-20Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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