APPLICATION
ANDA088724
TYPE
ANDA
ORIGINAL APPROVAL
1984-09-06
LATEST ACTION
1998-07-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METHYCLOTHIAZIDEDiscontinued
METHYCLOTHIAZIDE 5MG · TABLET · ORAL
Approval history
1998-07-17Manufacturing (CMC) · Supplement 17AP
1994-03-24Manufacturing (CMC) · Supplement 14AP
1994-03-24Labeling · Supplement 15AP
1991-06-20Labeling · Supplement 16AP
1988-08-15Manufacturing (CMC) · Supplement 9AP
1988-06-17Manufacturing (CMC) · Supplement 8AP
1988-06-17Manufacturing (CMC) · Supplement 10AP
1988-06-17Manufacturing (CMC) · Supplement 7AP
1987-11-17Manufacturing (CMC) · Supplement 5AP
1987-11-17Manufacturing (CMC) · Supplement 4AP
1985-12-27Manufacturing (CMC) · Supplement 3AP
1984-09-06OriginalAP
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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