APPLICATION
ANDA070035
TYPE
ANDA
ORIGINAL APPROVAL
1984-12-20
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 64 · standardAP
2024-07-08Labeling · Supplement 63 · standardAP
2024-06-20Labeling · Supplement 62 · standardAP
2022-04-05Labeling · Supplement 60 · standardAP
2022-04-05Labeling · Supplement 61 · standardAP
2019-08-13Labeling · Supplement 59 · standardAP
2014-06-30Labeling · Supplement 57 · standardAP
2013-08-02Labeling · Supplement 56 · standardAP
2001-08-30Manufacturing (CMC) · Supplement 42AP
2000-07-07Manufacturing (CMC) · Supplement 39AP
2000-03-23Manufacturing (CMC) · Supplement 38AP
1998-06-08Manufacturing (CMC) · Supplement 37AP
1997-08-28Manufacturing (CMC) · Supplement 35AP
1997-07-08Manufacturing (CMC) · Supplement 34AP
1997-03-06Labeling · Supplement 36AP
1996-08-16Manufacturing (CMC) · Supplement 33AP
1996-02-05Manufacturing (CMC) · Supplement 32AP
1995-11-14Labeling · Supplement 31AP
1995-10-03Manufacturing (CMC) · Supplement 28AP
1995-10-03Manufacturing (CMC) · Supplement 30AP
1995-10-03Manufacturing (CMC) · Supplement 29AP
1994-04-28Manufacturing (CMC) · Supplement 21AP
1994-04-28Manufacturing (CMC) · Supplement 24AP
1994-04-28Manufacturing (CMC) · Supplement 22AP
1994-04-28Manufacturing (CMC) · Supplement 23AP
1994-01-26Manufacturing (CMC) · Supplement 26AP
1994-01-26Manufacturing (CMC) · Supplement 27AP
1994-01-26Manufacturing (CMC) · Supplement 25AP
1993-08-31Manufacturing (CMC) · Supplement 18AP
1993-08-31Manufacturing (CMC) · Supplement 19AP
1993-07-30Manufacturing (CMC) · Supplement 20AP
1993-05-25Manufacturing (CMC) · Supplement 15AP
1993-05-25Manufacturing (CMC) · Supplement 13AP
1993-05-25Manufacturing (CMC) · Supplement 16AP
1993-05-25Manufacturing (CMC) · Supplement 14AP
1993-05-25Manufacturing (CMC) · Supplement 12AP
1993-05-25Manufacturing (CMC) · Supplement 17AP
1993-04-01Manufacturing (CMC) · Supplement 11AP
1993-04-01Manufacturing (CMC) · Supplement 9AP
1993-04-01Manufacturing (CMC) · Supplement 10AP
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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