APPLICATION
ANDA070027
TYPE
ANDA
ORIGINAL APPROVAL
1984-12-06
LATEST ACTION
2024-10-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METRONIDAZOLEPrescription
METRONIDAZOLE 250MG · TABLET · ORAL
Approval history
2024-10-10Labeling · Supplement 54 · standardAP
2024-07-08Labeling · Supplement 53 · standardAP
2024-06-20Labeling · Supplement 52 · standardAP
2022-03-22Labeling · Supplement 50 · standardAP
2022-03-22Labeling · Supplement 47 · standardAP
2019-08-14Labeling · Supplement 44 · standardAP
2019-08-14Labeling · Supplement 43 · standardAP
2017-09-05Labeling · Supplement 42 · standardAP
2014-12-24Manufacturing (CMC) · Supplement 37AP
2014-07-21Labeling · Supplement 41 · standardAP
2010-09-28Labeling · Supplement 35AP
2007-10-25Labeling · Supplement 29AP
2001-06-27Manufacturing (CMC) · Supplement 18AP
2001-05-29Manufacturing (CMC) · Supplement 19AP
2000-07-07Manufacturing (CMC) · Supplement 17AP
1997-05-21Labeling · Supplement 16AP
1994-05-11Manufacturing (CMC) · Supplement 15AP
1993-06-22Labeling · Supplement 14AP
1992-09-01Labeling · Supplement 13AP
1990-10-12Manufacturing (CMC) · Supplement 12AP
1989-10-24Labeling · Supplement 11AP
1986-04-22Manufacturing (CMC) · Supplement 8AP
1985-05-21Manufacturing (CMC) · Supplement 3AP
1985-05-21Manufacturing (CMC) · Supplement 1AP
1985-05-21Manufacturing (CMC) · Supplement 6AP
1985-05-21Manufacturing (CMC) · Supplement 4AP
1985-05-21Manufacturing (CMC) · Supplement 2AP
1984-12-06OriginalAP
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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