APPLICATION
NDA017386
TYPE
NDA
ORIGINAL APPROVAL
1973-11-27
LATEST ACTION
2019-05-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ZAROXOLYN · ReferenceDiscontinued
METOLAZONE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ZAROXOLYN · ReferenceDiscontinued
METOLAZONE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ZAROXOLYN · ReferenceDiscontinued
METOLAZONE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2002-04-15Manufacturing (CMC) · Supplement 33 · standardAP
2001-10-18Manufacturing (CMC) · Supplement 31 · standardAP
1999-08-13Labeling · Supplement 30 · standardAP
1997-07-14Manufacturing (CMC) · Supplement 29 · standardAP
1997-01-07Manufacturing (CMC) · Supplement 27 · standardAP
1995-05-23Labeling · Supplement 26 · standardAP
1994-05-04Manufacturing (CMC) · Supplement 25 · standardAP
1994-01-13Labeling · Supplement 24 · standardAP
1993-01-13Labeling · Supplement 23 · standardAP
1989-10-10Labeling · Supplement 22AP
1989-09-12Manufacturing (CMC) · Supplement 9 · standardAP
1988-12-09Manufacturing (CMC) · Supplement 21 · standardAP
1988-02-01Manufacturing (CMC) · Supplement 19 · standardAP
1987-09-30Labeling · Supplement 15AP
1987-08-26Manufacturing (CMC) · Supplement 20 · standardAP
1985-08-12Labeling · Supplement 18AP
1984-02-07Manufacturing (CMC) · Supplement 17 · standardAP
1984-02-07Manufacturing (CMC) · Supplement 16 · standardAP
1983-07-15Manufacturing (CMC) · Supplement 13 · standardAP
1983-07-15Manufacturing (CMC) · Supplement 12 · standardAP
1983-02-18Labeling · Supplement 14AP
1982-12-02Manufacturing (CMC) · Supplement 11 · standardAP
1982-12-02Manufacturing (CMC) · Supplement 10 · standardAP
1980-01-03Labeling · Supplement 8AP
1978-04-25Labeling · Supplement 5AP
1978-04-25Manufacturing (CMC) · Supplement 4 · standardAP
1977-05-11Manufacturing (CMC) · Supplement 6 · standardAP
1973-11-27Type 1 - New Molecular Entity · Original · standardAP
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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