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FDA NDA · NDA018818

METRONIDAZOLE

Sponsor: MUTUAL PHARM

APPLICATION
NDA018818
TYPE
NDA
ORIGINAL APPROVAL
1983-02-16
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

METRONIDAZOLEDiscontinued
METRONIDAZOLE 500MG · TABLET · ORAL
METRONIDAZOLEDiscontinued
METRONIDAZOLE 250MG · TABLET · ORAL

Approval history

1998-12-01Manufacturing (CMC) · Supplement 32AP
1997-05-21Labeling · Supplement 31AP
1994-12-23Manufacturing (CMC) · Supplement 30AP
1994-10-11Manufacturing (CMC) · Supplement 29AP
1992-04-03Manufacturing (CMC) · Supplement 23AP
1992-04-03Manufacturing (CMC) · Supplement 28AP
1992-04-03Manufacturing (CMC) · Supplement 26AP
1992-04-03Manufacturing (CMC) · Supplement 24AP
1991-07-18Labeling · Supplement 22AP
1991-06-07Labeling · Supplement 21AP
1991-05-08Manufacturing (CMC) · Supplement 19AP
1991-05-08Manufacturing (CMC) · Supplement 20AP
1991-04-01Manufacturing (CMC) · Supplement 17AP
1991-04-01Manufacturing (CMC) · Supplement 18AP
1988-11-29Labeling · Supplement 16AP
1987-04-03Manufacturing (CMC) · Supplement 13AP
1986-06-13Manufacturing (CMC) · Supplement 10AP
1986-06-13Manufacturing (CMC) · Supplement 8AP
1986-06-13Manufacturing (CMC) · Supplement 9AP
1985-07-31Manufacturing (CMC) · Supplement 6AP
1985-04-02Manufacturing (CMC) · Supplement 2AP
1983-02-16OriginalAP
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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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