APPLICATION
ANDA070049
TYPE
ANDA
ORIGINAL APPROVAL
1985-06-06
LATEST ACTION
2015-10-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TRIMETHOPRIMPrescription
TRIMETHOPRIM 100MG · TABLET · ORAL
Approval history
2015-10-27Labeling · Supplement 31 · standardAP
2007-02-21Labeling · Supplement 15AP
2002-05-01Manufacturing (CMC) · Supplement 13AP
2001-04-25Manufacturing (CMC) · Supplement 12AP
2001-02-02Labeling · Supplement 11AP
1997-02-26Labeling · Supplement 9AP
1991-12-23Manufacturing (CMC) · Supplement 8AP
1991-08-07Manufacturing (CMC) · Supplement 6AP
1991-01-28Manufacturing (CMC) · Supplement 7AP
1990-06-29Manufacturing (CMC) · Supplement 5AP
1985-12-09Manufacturing (CMC) · Supplement 1AP
1985-06-06OriginalAP
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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