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FDA NDA · NDA017476

SLOW-K

Sponsor: NOVARTIS

APPLICATION
NDA017476
TYPE
NDA
ORIGINAL APPROVAL
1975-04-25
LATEST ACTION
2004-11-24
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

SLOW-KDiscontinued
POTASSIUM CHLORIDE 8MEQ · TABLET, EXTENDED RELEASE · ORAL

Approval history

2004-11-24Labeling · Supplement 44 · standardLetterAP
2004-11-24Labeling · Supplement 45 · standardLetterAP
1999-04-28Manufacturing (CMC) · Supplement 43 · standardAP
1996-11-22Manufacturing (CMC) · Supplement 41 · standardAP
1992-06-30Manufacturing (CMC) · Supplement 40 · standardAP
1991-05-20Manufacturing (CMC) · Supplement 39 · standardAP
1989-08-08Manufacturing (CMC) · Supplement 38 · standardAP
1988-03-23Labeling · Supplement 37AP
1986-10-31Manufacturing (CMC) · Supplement 36 · standardAP
1985-08-21Manufacturing (CMC) · Supplement 35 · standardAP
1985-03-19Manufacturing (CMC) · Supplement 34 · standardAP
1984-12-14Manufacturing (CMC) · Supplement 33 · standardAP
1984-05-22Manufacturing (CMC) · Supplement 32 · standardAP
1983-04-06Manufacturing (CMC) · Supplement 30 · standardAP
1982-10-22Manufacturing (CMC) · Supplement 29 · standardAP
1982-07-08Manufacturing (CMC) · Supplement 17 · standardAP
1982-07-02Manufacturing (CMC) · Supplement 23 · standardAP
1981-09-14Manufacturing (CMC) · Supplement 28 · standardAP
1981-09-14Manufacturing (CMC) · Supplement 27 · standardAP
1981-07-21Manufacturing (CMC) · Supplement 26 · standardAP
1981-04-07Manufacturing (CMC) · Supplement 14 · standardAP
1980-06-13Manufacturing (CMC) · Supplement 25 · standardAP
1980-01-21Manufacturing (CMC) · Supplement 24 · standardAP
1980-01-03Labeling · Supplement 18AP
1979-08-03Manufacturing (CMC) · Supplement 20 · standardAP
1979-08-03Manufacturing (CMC) · Supplement 19 · standardAP
1979-08-03Manufacturing (CMC) · Supplement 21 · standardAP
1979-06-29Manufacturing (CMC) · Supplement 13 · standardAP
1979-05-04Manufacturing (CMC) · Supplement 22 · standardAP
1978-01-09Manufacturing (CMC) · Supplement 16 · standardAP
1977-06-27Labeling · Supplement 15AP
1977-02-08Manufacturing (CMC) · Supplement 12 · standardAP
1977-02-08Manufacturing (CMC) · Supplement 10 · standardAP
1977-02-08Manufacturing (CMC) · Supplement 11 · standardAP
1976-06-29Manufacturing (CMC) · Supplement 8 · standardAP
1976-06-07Manufacturing (CMC) · Supplement 9 · standardAP
1976-04-01Manufacturing (CMC) · Supplement 4 · standardAP
1976-04-01Manufacturing (CMC) · Supplement 7 · standardAP
1976-01-09Manufacturing (CMC) · Supplement 2 · standardAP
1975-11-18Manufacturing (CMC) · Supplement 3 · standardAP
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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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